[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-delirium\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-delirium":32},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,51,80,102,128,154,174,209,241,275,305,328,360,378,405,429,450,470,497,526,554,575,604,630,658],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100649604","perioperative-transcranial-photobiomodulation-and-delayed-neurocognitive-recovery-in-older-patients-100649604",false,"NCT07736092","Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients","Impact of Perioperative Transcranial Photobiomodulation on Delayed Neurocognitive Recovery in Older Patients After Surgery: a Randomized, Double-blind, Pseudo-modulation-controlled Preliminary Clinical Trial","Inclusion Criteria:\n\n* Aged 65 years or older.\n* Preoperative Mini-Mental State Examination (MMSE) \\\u003C27.\n* Scheduled to undergo non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\>1 hour.\n* Planned hospital stay of at least 1 day before surgery and at least 2 days after surgery.\n\nExclusion Criteria:\n\n* Communication barriers before surgery due to coma, severe dementia, or language disorders.\n* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis, or delirium before surgery.\n* History of brain injury, tumors, or surgery, or intracranial metal implants, or skin or soft tissue injuries on the head or face.\n* History of ischemic or hemorrhagic stroke within 3 months before surgery.\n* An American Society of Anesthesiologists class ≥ IV.\n* Enrolled in other interventional studies.\n* Other conditions deemed unsuitable for study participation.",true,"ALL","65 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"NA","Delayed neurocognitive recovery is a common neurocognitive complication in older patients after surgery, especially those with preoperative neurocognitive decline. Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. This technique has been used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce the incidence of delayed neurocognitive recovery in older patients with pre-existing neurocognitive impairment.",[28,29,30,31,32],"Older Adults","Surgery","Transcranial Photobiomodulation","Delayed Neurocognitive Recovery","Postoperative Delirium",[34,29,35,36,37],"Older adults","Transcranial photobiomodulation","Delayed neurocognitive recovery","Postoperative delirium","RECRUITING","2026-08-07",{"date":41,"type":42},"2026-08-10","ACTUAL",{"date":44,"type":42},"2026-08-05",{"date":46,"type":22},"2027-07",{"name":48,"class":49},"Peking University First Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":17,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100616779","creatine-and-perioperative-brain-health-100616779","NCT07310043","Creatine and Perioperative Brain Health","Creatine Intervention in Older Adults to Improve Perioperative Brain Health: a Randomized Controlled Trial (CREATE Trial)","CREATE","Inclusion Criteria:\n\n* Patients scheduled for elective surgery under general anesthesia\n\nExclusion Criteria:\n\n* History of creatine deficiency disorders\n* Renal or neurodegenerative disorders\n* History of stroke or significant head trauma, presence of intracranial mass lesions\n* Inability to give informed consent","60 Years","85 Years",{"count":62,"type":22},120,[25],"The overall goal of this study is to evaluate the feasibility of perioperative oral creatine supplementation and to explore its effects on cognitive function and physiological responses to surgery in older adults. Creatine is commonly used to enhance athletic performance, but it can also have positive effects on the brain. Since surgery can alter thinking, memory, and attention patterns in some patients, we will assess whether creatine affects these changes in older adults undergoing surgery.",[66,32],"Neurocognitive Disorders",[68,69,70],"Perioperative Brain Health","Creatine","Perioperative Neurocognitive Disorders","NOT_YET_RECRUITING","2026-08-06",{"date":41,"type":42},{"date":75,"type":22},"2026-09-01",{"date":77,"type":22},"2028-08-30",{"name":79,"class":49},"Massachusetts General Hospital",{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":50},"100611366","postoperative-delirium-in-patients-undergoing-cardiac-surgery-100611366","NCT07239648","Postoperative Delirium in Patients Undergoing Cardiac Surgery","A Real-World Single-Center Bidirectional Cohort Study on Postoperative Delirium in Patients Undergoing Cardiac Surgery","Inclusion Criteria:\n\n1. 18 years old and above\n2. Patients undergoing elective cardiac surgery\n\nExclusion Criteria:\n\n1. Organ transplantation surgery\n2. Pregnant patients\n3. Diagnosed with dementia or mental illness (such as schizophrenia) before surgery","18 Years",{"count":89,"type":22},1500,"OBSERVATIONAL","Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between \"preoperative exposure factors and postoperative delirium incidence\" and \"postoperative delirium and long-term adverse outcomes\", and clarify the predictive factors and prognostic impacts of postoperative delirium.",[32],"2026-08-02",{"date":95,"type":42},"2026-08-04",{"date":97,"type":42},"2025-10-31",{"date":99,"type":22},"2027-12-31",{"name":101,"class":49},"Xijing Hospital",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":50},"100563726","phase-3-dexmedetomidine-in-reducing-postoperative-delirium-in-cardiac-surgery-patients-100563726","NCT06619912","Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients","Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients：a Single-center, Double- Blind, Controlled Trial","DREAMS","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Cardiac surgery with cardiopulmonary bypass.\n3. Ability to provide consent.\n\nExclusion Criteria:\n\n1. Preoperative schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, history of neurosurgery, or Mini-mental State Examination(MMSE) score: illiteracy\\\u003C17, primary school level\\\u003C20, high school level \\\u003C24.\n2. Patients with sick sinus syndrome, severe sinus bradycardia (heart rate\\\u003C50 beats\u002Fminute), grade II or above atrioventricular block, and no pacemaker implanted.\n3. Unable to communicate due to coma, severe dementia, or language barriers prior to surgery.\n4. Patients with severe liver dysfunction (Child Pugh C grade), renal dysfunction (preoperative dialysis), ASA grade V or expected survival ≤ 24 hours.\n5. Heart transplant surgery\n6. Surgery for congenital heart disease.\n7. Deep hypothermic circulatory arrest surgery.\n8. Already enrolled in other study patients.\n9. Refuse to participate.",{"count":111,"type":22},686,[113],"PHASE3","Delirium is a common consequence of cardiac surgery and associates with poor outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Dexmedetomidine may be effective in reducing delirium. The aim of this study was to demonstrate preoperative dexmedetomidine nasal spray in cardiac surgery patients can reduce postoperative delirium by improving preoperative sleep.",[32,116],"Preoperative Sleep Disorder",[118,119,120,121],"postoperative delirium","preoperative sleep disorder","dexmedetomidine","cardiopulmonary coupling",{"date":44,"type":42},{"date":124,"type":42},"2025-03-03",{"date":126,"type":22},"2027-03-30",{"name":101,"class":49},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":50},"100648393","cognitive-dysfunction-and-delirium-after-tur-m-in-elderly-patients-100648393","NCT07719712","Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients","Prediction of Postoperative Cognitive Dysfunction and Delirium: A Prospective Observational Study to Develop a Risk Score in Elderly Patients Undergoing Transurethral Resection","POCDTURMSTUD","Inclusion Criteria:\n\n* Age ≥65 years\n* Scheduled for transurethral resection procedure\n* ASA physical status I-III\n* Able to provide informed consent\n* Adequate cognitive function to complete preoperative assessment\n\nExclusion Criteria:\n\n* Pre-existing diagnosis of dementia or severe cognitive impairment (MoCA \\\u003C18)\n* Severe visual or hearing impairment preventing cognitive assessment\n* History of psychiatric disease requiring antipsychotic or sedative medication\n* Neurological disorders associated with increased delirium risk (e.g., Parkinson's disease, epilepsy)\n* Inability to complete study assessments",{"count":137,"type":22},150,"Elderly patients undergoing transurethral resection are at increased risk of postoperative cognitive dysfunction (POCD) and delirium, which are associated with prolonged hospital stay, increased morbidity, and decreased quality of life. Identifying patients who are more likely to develop postoperative cognitive dysfunction or delirium remains a practical challenge in daily clinical practice. Better recognition of these patients may help tailor perioperative care and improve outcomes.\n\nThis prospective observational study aims to identify perioperative factors associated with POCD and delirium in elderly patients undergoing transurethral resection and to develop a clinically applicable risk prediction model. Cognitive function and delirium are assessed using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).\n\nCognitive function and delirium will be evaluated using the Montreal Cognitive Assessment (MoCA) and the Confusion Assessment Method (CAM).\n\nThe results of this study may support clinicians in recognizing vulnerable patients earlier and may contribute to more individualized perioperative management.",[32,140,141],"Postoperative Cognitive Dysfunction","Cognitive Dysfunction",[140,143,144],"Delirium","Transurethral Resection","2026-07-20",{"date":147,"type":42},"2026-07-22",{"date":149,"type":42},"2026-04-05",{"date":151,"type":22},"2026-11-15",{"name":153,"class":49},"Muğla Sıtkı Koçman University",{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100645531","phase-2-lemborexant-use-for-cognition-improvement-in-postoperative-delirium-in-elderly-patients-a-randomized-controlled-trial-100645531","NCT07695285","Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥60 years old;\n* ASA classification I to III;\n* Patients undergoing elective surgery;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Tracheal intubation is expected to be retained after the operation;\n* Previous history of alcohol or drug abuse;\n* Severe abnormalities in liver and kidney functions;\n* Long-term use of sedative-hypnotic drugs;\n* Severe sleep apnea and COPD;\n* Inability to cooperate in mental state;\n* Craniocerebral surgery\n* Pregnant and lactating patients;\n* Use drugs that affect orexin metabolism.",{"count":161,"type":22},992,[163],"PHASE2","This prospective, randomized controlled trial aims to investigate the perioperative use of lemborexant, an orexin receptor antagonist, for reducing postoperative delirium (POD) in elderly patients undergoing general anesthesia.",[32],"2026-07-12",{"date":168,"type":42},"2026-07-14",{"date":75,"type":22},{"date":171,"type":22},"2029-12-31",{"name":173,"class":49},"Beijing Tiantan Hospital",{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100626159","orthopedic-procedures-and-postoperative-delirium-in-older-adults-in-the-czech-republic-100626159","NCT07432009","Orthopedic Procedures and Postoperative Delirium in Older Adults in the Czech Republic","Orthopedic Procedures and Postoperative Delirium in the Czech Republic","ORTOPODCZ","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Elective total hip arthroplasty in general or regional anesthesia\n* ASA physical status I-III\n* Ability to understand and cooperate during testing; no severe sensory impairment (compensatory aids allowed)\n* Expected postoperative hospitalization in ICU, PACU, or standard ward\n\nExclusion Criteria:\n\n* Glasgow Coma Scale ≤ 14\n* Limited legal capacity\n* Active psychiatric disorder (e.g., psychotic disorder, bipolar disorder)\n* Active oncological disease\n* Chronic use of strong opioids\n* Premedication with anxiolytics or antipsychotics during preanesthetic evaluation\n* Acute reoperation within 3 months of primary surgery\n* Refusal to participate or withdrawal of consent",{"count":183,"type":22},400,"This multicenter, prospective, non-interventional observational study (ORTOPODCZ) investigates the association between preoperative cognitive impairment and postoperative delirium (POD) in older adults undergoing elective total hip arthroplasty in the Czech Republic. Postoperative delirium is a frequent and serious neurocognitive complication in senior surgical patients and is associated with increased morbidity, mortality, prolonged hospitalization, and impaired functional and cognitive outcomes. Despite international recommendations, routine preoperative cognitive screening remains insufficiently implemented.\n\nThe study evaluates the predictive value of the ALBA test, a brief cognitive screening tool, performed during the pre-anesthetic assessment. Postoperative delirium will be assessed using the validated CAM-ICU instrument for up to 72 hours after surgery. Secondary objectives include assessing the relationship between POD and frailty, polypharmacy, comorbidities, type of anesthesia, intraoperative hemodynamics, blood loss, vasoactive support, and postoperative complications.\n\nApproximately 300-400 participants aged ≥65 years will be enrolled across seven centers. No additional procedures, biological sampling, or deviations from standard clinical care are required. Data will be collected in REDCap and analyzed according to a predefined statistical analysis plan. The study aims to provide robust evidence supporting the integration of cognitive screening into routine preoperative evaluation and to describe feasibility and implementation requirements for the ALBA test in clinical practice.",[186,187,28,188,32],"Frailty","Cognitive Impairment","Hip Arthroplasty",[190,191,192,193,70,194,195,196,197,198],"ALBA test","CAM-ICU","Cognitive Screening","Geriatric Patients","Polypharmacy","Clinical Frailty Scale","Total Hip Replacement","Observational Study","Prospective Cohort","2026-07-08",{"date":201,"type":42},"2026-07-09",{"date":203,"type":42},"2026-04-24",{"date":205,"type":22},"2030-03-31",{"name":207,"class":49},"Tomas Bata Hospital, Czech Republic",7,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":221,"studyType":90,"phases":4,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":50},"100646455","dynamic-multimodal-delirium-warning-after-cardiac-surgery-100646455","NCT07686900","Dynamic Multimodal Delirium Warning After Cardiac Surgery","A Dynamic Early Warning System for Postoperative Delirium After Cardiac Surgery Integrating EEG, Cerebral Oxygenation, Hemodynamic Physiology, and Clinical Risk Factors","DEW-POD","Inclusion Criteria:\n\n1. Adult patients (18-80 years) admitted to the Department of Critical Care Medicine.\n2. Underwent cardiac surgery.\n3. Under multimodal monitoring (including EEG, cerebral oximetry, and invasive arterial blood pressure).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Pre-existing dementia, history of psychiatric disorders, or long-term use of antipsychotic medications, preventing accurate assessment of delirium.\n2. Preoperative severe hepatic or renal insufficiency (Child-Pugh Class C or eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n3. Severe craniocerebral injury, intracranial space-occupying lesion, or history of epilepsy.\n4. Inability to obtain continuous EEG or cerebral oximetry signals due to technical reasons (e.g., scalp injury, abnormal probe placement site).\n5. Patients expected to die within 24 hours.\n6. Patients deemed unsuitable for the study by the investigator.","15 Years","80 Years",{"count":220,"type":22},200,"28 Days","After heart surgery, up to half of all patients may develop a state of sudden confusion called postoperative delirium. This condition can lead to longer time on a breathing machine, extended stays in the intensive care unit (ICU), and a slower overall recovery. Currently, doctors have no reliable way to predict delirium early enough to take preventive action. This study aims to build a computer-based early warning system. The system will combine continuous, real-time measurements of brain waves (EEG), the oxygen level in the brain, and heart and blood pressure function. It will also include information about each patient's health status. By analyzing all of these signals together, the model is designed to give an alert 1 to 6 hours before delirium might start, giving the care team a window of time to intervene. The study will take place in the ICU at Zhongda Hospital, Southeast University. Adults between 18 and 80 years old who are admitted to the ICU after heart surgery will be invited to participate. All patients will receive the usual standard of care; the study does not test any new treatment. Participation means the investigators will continuously record the brain, oxygen, and heart signals that are already being monitored, and a researcher will regularly assess the patient's thinking and alertness with a simple bedside check.",[32,224],"Cardiac Surgical Procedures",[32,226,227,228,229,230,231,232,233],"Cardiac Surgery","Electroencephalography","EEG","Cerebral Oximetry","Near-Infrared Spectroscopy","Hemodynamics","Multimodal Monitoring","Early Warning System","2026-07-06",{"date":199,"type":42},{"date":234,"type":22},{"date":238,"type":22},"2027-12-30",{"name":240,"class":49},"Southeast University, China",{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100485045","impact-of-personalised-cardiac-anaesthesia-and-cerebral-autoregulation-on-neurological-outcomes-in-patients-undergoing-cardiac-surgery-100485045","NCT05595954","Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery","Impact of Personalised Cardiac Anaesthesia and Cerebral Autoregulation on Neurological Outcomes in Patients Undergoing Cardiac Surgery (PRECISION)","PRECISION","Inclusion Criteria:\n\n* Elective primary or reoperative coronary artery bypass graft and\u002For valvular and\u002For ascending aorta surgery requiring cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Surgery requiring moderate (28-31.9ºC) or deep (\\\u003C28ºC) hypothermic circulatory arrest;\n* Heart and\u002For lung transplantation;\n* Urgent (within 24 hours) and emergency surgery;\n* Inability to follow procedures or insufficient knowledge in English, German or French;\n* Inability to give consent.\n\nParticipants who undergo cardiac surgery under minimal extracorporeal circulation will also be excluded.",{"count":250,"type":22},500,"This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.",[32,253,140],"Postoperative Stroke",[255,256,257,258,118,259,260,261,262,263,264],"cerebral autoregulation","hypotension","neurological outcomes","adverse neurological events","postoperative stroke","postoperative cognitive decline","personalised cardiac anaesthesia","cardiac surgery","near-infrared spectroscopy","transcranial Doppler","2026-06-25",{"date":267,"type":42},"2026-06-30",{"date":269,"type":42},"2023-01-23",{"date":271,"type":22},"2027-06",{"name":273,"class":49},"University Hospital, Basel, Switzerland",4,{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":291,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100535786","effects-of-intraoperative-targeted-temperature-management-on-incidence-of-postoperative-delirium-and-long-term-survival-100535786","NCT06256354","Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival","Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival in Older Patients Having Major Cancer Surgery: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Age ≥65 years.\n2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.\n\nExclusion Criteria:\n\n1. Preoperative fever (tympanic temperature ≥38℃).\n2. Known or suspected preoperative infection.\n3. Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.\n4. Unable to communicate due to severe dementia, language barrier, or coma.\n5. Critically ill (Left ventricular ejection fraction \\\u003C30%, Child-Pugh grades C, requirement of renal replacement therapy, American Society of Anesthesiologists physical status\\>IV, or expected survival \\\u003C24 hours).\n6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.\n7. Planned to undergo therapeutic hypothermia.\n8. Body mass index \\>30 kg\u002Fm2 (to facilitate thermal management).\n9. Have participated in this study previously.\n10. Any other conditions that are considered unsuitable for study participation.",{"count":283,"type":22},3992,[25],"Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery.",[287,288,289,32,290],"Cancer Surgery","Intraoperative Hypothermia","Targeted Temperature Management","Long-term Survivors",[292,293,294,37,295],"Cancer surgery","Intraoperative hypothermia","Targeted temperature management","Long-term survival","2026-06-18",{"date":298,"type":42},"2026-06-23",{"date":300,"type":42},"2024-05-29",{"date":302,"type":22},"2032-06",{"name":48,"class":49},36,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":313,"conditions":314,"keywords":315,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":50},"100632366","preoperative-distress-and-postoperative-delirium-in-elderly-patients-undergoing-major-orthopedic-surgery-100632366","NCT07512752","Preoperative Distress and Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery","The Association Between Preoperative Distress and Postoperative Delirium, Pain, and Length of Hospital Stay in Elderly Patients Undergoing Major Orthopedic Surgery","Inclusion Criteria\n\n* Age ≥65 years\n* Undergoing major orthopedic surgery, including:\n* Hip fracture surgery\n* Primary or revision hip arthroplasty\n* Primary knee arthroplasty\n* Ability to provide informed consent or availability of a legally authorized representative\n\nExclusion Criteria\n\n* Known diagnosis of severe dementia or significant cognitive impairment\n* Presence of preoperative delirium or an active diagnosis of delirium\n* Severe hearing or visual impairment preventing effective communication\n* History of intracranial surgery or neurological diseases significantly increasing the risk of delirium (e.g., advanced Parkinson's disease, severe stroke sequelae)\n* Planned postoperative sedation in the intensive care unit",{"count":137,"type":22},"Postoperative delirium is a common and serious complication in elderly patients undergoing major orthopedic surgery and is associated with increased morbidity, prolonged hospital stay, and higher healthcare costs. Preoperative psychological distress has been suggested as a potential risk factor influencing postoperative outcomes; however, its relationship with delirium and other clinical outcomes remains insufficiently explored.\n\nThis prospective observational study aims to investigate the association between preoperative distress levels and postoperative delirium, pain intensity, and length of hospital stay in elderly patients undergoing major orthopedic surgery. Preoperative distress will be assessed using validated tools, and postoperative outcomes including delirium incidence, pain scores, and hospital stay duration will be recorded and analyzed.\n\nThe findings of this study are expected to contribute to improved perioperative risk stratification and may support the development of targeted interventions to reduce postoperative complications in this vulnerable patient population.",[32],[32,316,317,318],"Preoperative Distress","Pain","Length of Hospital Stay","2026-06-09",{"date":321,"type":42},"2026-06-11",{"date":323,"type":42},"2026-02-19",{"date":325,"type":22},"2026-06",{"name":327,"class":49},"Elazıg Fethi Sekin Sehir Hastanesi",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":19,"enrollmentInfo":335,"targetDuration":337,"studyType":90,"phases":4,"briefSummary":338,"conditions":339,"keywords":347,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":50},"100643122","the-effects-of-anesthesia-on-postoperative-cognitive-functions-in-patients-undergoing-sleeve-gastrectomy-100643122","NCT07637357","The Effects of Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy","The Effects of Total Intravenous Anesthesia and Inhalational Anesthesia on Postoperative Cognitive Functions in Patients Undergoing Sleeve Gastrectomy","Inclusion Criteria:\n\nPatients of both sexes, Patients Aged between 18 and 65 years, Patients classified as ASA(American Society of Anesthesiologists) physical status I- III, Patients with a BMI (Body Mass Index) between 35 and 50 kg\u002Fm² scheduled to undergo sleeve gastrectomy as a type of bariatric surgery for the first time.\n\nExclusion Criteria:\n\nPatients classified as ASA physical status 4 or high, Patients with known allergy to any of the drugs used in the study, Patients with bleeding disorders, Patients with serum creatinine levels \\>2 mg\u002FdL, Patients with severe arrhythmias and EF\\\u003C30%, Patients with a known history of drug abuse are excluded.",{"count":336,"type":22},60,"3 Months","In this study, the investigators want to examine the effects of intravenous anesthetic drugs and gases on cognitive functions in the postoperative period in individuals who will undergo surgery for obesity. The investigators believe that the anesthesia method we apply with inhalation gases is also as reliable method as total intravenous anesthesia for postoperative cognitive functions in these patients who undergoe sleeve gastrectomy.\n\nThe anesthesia method applied intravenously and with inahalational gases have been applied safely for many years. Comparisons between these two anesthesia technics in obese individuals and for postoperative cognitive dysfunctions are limited.\n\nStudies on the examination of cognitive functions in postoperative patients have gained momentum with the use of neuropsychiatric tests performed on patients who have undergone cardiac surgery and these tests have also been performed on individuals who have undergone non-cardiac surgery. And yet, similar declines in cognitive functions have been observed. For these reasons, the effects of surgery itself and anesthesia methods on cognitive functions have been studied up to date.\n\nIn this study, the investigators plan to evaluate patients who will undergo obesity surgery in both anesthesia methods by the recovery times from anesthesia and the residual effects of anesthesia, and after awakening they plan to evaluate their cognitive functions with neuropsychiatric tests that will be performed at certain intervals.",[340,341,342,32,343,31,344,345,346],"POCD - Postoperative Cognitive Dysfunction","Recovery Time","Postoperative Neurocognitive Disorder","Bariatric Sleeve Gastrectomy","Total Intravenous Anesthesia","Inhalational Anesthesia","Cognitive Functions",[348,349,350,351],"total intravenous anesthesia","inhalational anesthesia","sleeve gastrectomy","postoperative cognitive dysfunctions","2026-06-04",{"date":319,"type":42},{"date":355,"type":42},"2025-09-30",{"date":357,"type":22},"2026-07-30",{"name":359,"class":49},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100640121","prosevo-trial-propofol-sevoflurane-delirium-target-trial-emulation-100640121","NCT07612579","PROSEVO Trial (Propofol-Sevoflurane Delirium Target Trial Emulation)","Inclusion Criteria:\n\n* Adult patients (≥18 years) at the Department of Anesthesiology and Intensive Care Medicine (CCM\u002FCVK) and the Department of Anesthesiology and Intensive Care Medicine (CBF) at Charité,\n* undergoing elective surgery under general anesthesia\n* with a planned surgery duration of ≥ 30 minutes\n\nIn addition, the following conditions must be met:\n\n* The surgery must be the patient's first surgery per hospital stay to avoid dependencies and repeated measurements of the same person within a short time frame;\n* The surgeries take place at Charité between January 1, 2011, and December 31, 2025.\n\nExclusion Criteria:\n\nPatients in any of the following situations are excluded:\n\n1. Cardiac surgery (this patient group requires specialized monitoring strategies and has postoperative delirium risk profiles that differ significantly from those of other types of surgery)\n2. preoperatively diagnosed delirium, defined as positive results on the Nursing Delirium Screening Scale (NU-DESC) or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during preoperative evaluations;\n3. severe preoperative cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score \\\u003C15 points, or\n4. preoperatively documented severe dementia\n5. neurosurgical procedures (neurosurgical patients require specialized monitoring protocols and differ from other surgical patients in their postoperative delirium (POD) symptoms)\n6. Patients who were already admitted to intensive care units prior to their elective surgery (these patients already have increased mortality and a different risk profile)\n7. Patients who were already intubated or sedated prior to surgery (this group cannot undergo standardized POD screening)\n8. High preoperative risk for postoperative nausea and vomiting (PONV) (specifically, patients with documented PONV grade 3 or PONV grade 4 risk are excluded, as this group is indicated for anesthesia with propofol)",{"count":367,"type":22},100000,"The results of this study have significant implications for clinical practice and guideline development. The current European guideline on postoperative Delirium prevention (ESAIC 2024) explicitly identifies a lack of large, adequately powered studies comparing different anesthetic techniques and is therefore currently unable to provide clear recommendations on the selection of an optimal technique. This study will close this knowledge gap and thus support future guideline recommendations. The results could show that a particular anesthetic technique (e.g., propofol) is associated with a significantly lower risk of postoperative delirium; if so, this would have immediate implications for modifying standard anesthesia protocols in hospitals.\n\nFurthermore, Delirium is a significant public health challenge in aging societies. With demographic aging, the number of older patients undergoing surgery is continuously increasing. The societal costs of Delirium are estimated at several billion euros per year in major industrialized nations. A reduction in the incidence of postoperative Delirium by just 10% through optimization of the anesthetic procedure would therefore have major health economic implications.",[32],"2026-06-03",{"date":352,"type":42},{"date":370,"type":42},{"date":374,"type":22},"2027-12",{"name":376,"class":49},"Charite University, Berlin, Germany",2,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":4},"100640937","phase-1-opioid-free-anesthesia-and-postoperative-delirium-100640937","NCT07603596","Opioid-free Anesthesia and Postoperative Delirium","Effect of Opioid-free Anesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery","Inclusion Criteria:\n\n1. Patients who plan to undergo elective gastrointestinal surgery under general anaesthesia\n2. Age ≥65 years\n3. American Society of Anaesthesiologists (ASA) grade I-III\n4. Body mass index (BMI) of 18.0-30.0 kg\u002Fm²\n5. Frailty: mFI ≥ 0.27\n6. Signed informed consent\n\nExclusion Criteria:\n\n1. Patients undergoing emergency surgery\n2. Patients with language disorders or severe hearing or vision impairment that prevent communication\n3. Patients with a history of neurological and psychiatric disorders, including Alzheimer's disease (AD), other types of dementia, stroke, and psychosis\n4. Patients with long-term use of psychotropic medications (such as clozapine, risperidone, olanzapine, haloperidol, and chlorpromazine)\n5. Patients who have undergone cardiac surgery or craniocerebral surgery within the past year\n6. Patients who have participated in other relevant clinical trials within the past 3 months\n7. Patients with preoperative cognitive impairment (Telephone Interview for Cognitive Status-modified (TICS-m) score ≤ 27), as determined via the TICS-M test\n8. Each patient can be included only once, regardless of whether the reason for the second surgery is related to the primary cause\n9. Let me know if you need this in a different bullet style (e.g., asterisks) or with indentation adjustments.",{"count":386,"type":22},174,[388],"PHASE1","Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 654 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients.",[32,391],"Gastrointestinal Tumors",[393,394,118,395],"elderly patients","opioid-free anaesthesia","gastrointestinal surgery","2026-05-16",{"date":398,"type":42},"2026-05-22",{"date":400,"type":22},"2026-05-01",{"date":402,"type":22},"2028-06-30",{"name":404,"class":49},"Qianfoshan Hospital",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":427,"locationsCount":50},"100615777","naples-prognostic-score-for-predicting-postoperative-delirium-100615777","NCT07297017","Naples Prognostic Score for Predicting Postoperative Delirium","Naples Prognostic Score for Predicting Postoperative Delirium in the Elderly Undergoing Hip Fracture Surgeries","Inclusion Criteria:\n\n* The elderly age≥60 years\n* American Society of Anesthesiologists (ASA) classification II∼IV\n* Patients undergoing hip fracture surgery\n* Patients who had a complete blood sample were taken preoperatively\n\nExclusion Criteria:\n\n* Patient refused to participate and consent\n* Patients with a history of mild cognitive impairment (MCI), dementia, and delirium\n* Ptients with known preoperative infections (pulmonary infection, urinary infection, and sepsis).",{"count":413,"type":22},168,"Naples Prognostic Score (NPS) originally developed to predict outcomes in inflammatory and malignant conditions; we asked if it can effectively predict postoperative delirium (POD) in elderly patients undergoing hip surgery? NPS integrate markers such as albumin, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio-all of which have been linked to adverse postoperative outcomes including POD.",[32],[417,418,419,420],"POD","elderly","geriatric","NPS","2026-05-13",{"date":423,"type":42},"2026-05-14",{"date":425,"type":42},"2026-01-10",{"date":374,"type":22},{"name":428,"class":49},"South Valley University",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":50},"100544928","digital-sleep-optimization-for-brain-health-outcomes-in-older-surgical-patients-100544928","NCT06375265","Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients","A Pilot Study of Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST)","SLEEP-BOOST","Inclusion Criteria:\n\n1. Adults ≥ 65 years old\n2. Scheduled for an elective orthopedic total joint replacement procedure (knee\u002Fhip)\n3. At least mild insomnia (ISI score of ≥10 on telephone screening or RedCap screening questionnaire)\n\n5\\. Own a smart phone 6. Willingness to use the dCBT-I app and actigraphy.\n\nExclusion Criteria:\n\n1. Current or previous CBT-I exposure in the last 6 months prior to the start of the study\n2. Rapidly progressive illnesses\u002Flife expectancy \\\u003C6 months\n3. Active psychosis\u002Fsuicidal ideation\n4. Irregular shift work\u002Fsleep patterns\n5. Moderate-severe sleep apnea (apnea\u002Fhypopnea index ≥15) without CPAP compliance per chart review\n6. Sleep disorders other than insomnia or apnea\n7. Cognitive impairment (diagnosis of dementia)\n8. Initiation, discontinuation, or dose change of sleep-affecting prescription medications within 1 month prior to study start or during the intervention period; not excluded if stable sleep-affecting medications in the prior month (by clinical review)\n9. No surgery within 12 months of consented, eligibility will be reassessed if surgery is delayed by more than 3 months",{"count":438,"type":22},50,[25],"The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).",[442,32,31,342],"Insomnia","2026-05-11",{"date":423,"type":42},{"date":446,"type":42},"2025-01-15",{"date":448,"type":22},"2026-12-31",{"name":79,"class":49},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":377},"100416831","incidence-of-postoperative-delirium-in-elderly-patients-undergoing-non-cardiac-surgery-100416831","NCT04707794","Incidence of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery","The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study","Inclusion Criteria:\n\n* Patients of age \\>65yrs\n* Either sex\n* ASA physical status I - III\n* Elective non-cardiac surgical procedures under general anesthesia\n* Clinical Frailty Score (CFS): 1-8\n* Patients requiring at least 24 hours of postoperative inpatient care.\n\nExclusion Criteria:\n\n* Clinical Frailty Score (CFS) of 9\n* Patients diagnosed with dementia, severe psychiatric or neurological diseases\n* Recent surgery within past 3-months\n* History of recent head injury in the preceding 3 months\n* Patients with uncompensated cardiovascular disease, hepato-renal insufficiency and uncontrolled endocrine disease\n* Patients on anti-depressant, anti-anxiety, anti-convulsant and anti-parkinsonism medications\n* Preoperative haemoglobin \\\u003C 8 gm % and serum albumin \\\u003C 3.5mg\u002Fdl\n* Patient inability to give informed consent\n* Presence of preoperative delirium as assessed by 4A'S Test (score ≥ 4)",{"count":458,"type":22},270,"Postoperative delirium (POD) is the most common adverse neurologic complication that can occur in patients of any age. Its incidence varies across age groups and is substantially influenced by patient-related risk factors. POD occurs in 17%-61% of major surgical procedures. Several risk factors which contribute to the development of POD include age more than 60 years, pre-existing cognitive dysfunction, presence of comorbidities, sensorial deficits, malnutrition, polypharmacy, impaired physical mobility and frailty. Postoperative delirium has several wide ranging and adverse outcomes that are consistently associated with delirium such as mortality, increased length of hospital stay, and increased hospital costs. A recently devised tool for rapid assessment of delirium is the 4 A's test. It has now been validated for identifying delirium in the surgical population. The proposed prospective observational study will be conducted on 150 patients belonging to ASA Physical Status I-III of either sex, scheduled to undergo non-cardiac surgery under general anaesthesia (GA), requiring at least 24 hours of postoperative inpatient care. This prospective, observational study aims to evaluate the incidence, risk factors and outcomes of postoperative delirium in elderly patients more than 65 years of age undergoing non-cardiac surgery.",[32],"2026-04-22",{"date":463,"type":42},"2026-04-27",{"date":465,"type":42},"2021-01-14",{"date":467,"type":22},"2028-09",{"name":469,"class":49},"Sir Ganga Ram Hospital",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":477,"enrollmentInfo":478,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":481,"conditions":482,"keywords":486,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":377},"100633180","phase-4-impact-of-esketamine-on-delayed-neurocognitive-recovery-in-older-patients-100633180","NCT07523334","Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients","Impact of Esketamine on Delayed Neurocognitive Recovery in Older Patients Undergoing Non-cardiac Surgery: a Two-center, Dose-exploring Pilot Trial","Inclusion Criteria:\n\n1. Aged \\>=65 but \\\u003C= 90 years;\n2. Scheduled to undergo non-cardiac surgery with an expected duration of \\>= 2 hours under general anesthesia;\n3. Requiring patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n1. Unable to communicate preoperatively due to visual or auditory impairment, language barrier, or severe dementia;\n2. Comorbid with schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;\n3. Traumatic brain injury or neurosurgery;\n4. Severe hepatic dysfunction (Child-Pugh Class C), severe renal dysfunction (receiving dialysis preoperatively), or American Society of Anesthesiologists physical status classification \\>= Ⅳ;\n5. Expected admission to the Intensive Care Unit with endotracheal intubation after surgery;\n6. Anaphylaxis to esketamine;\n7. Participation in other clinical studies, or any other conditions that are considered unsuitable to be involved in the study.","90 Years",{"count":62,"type":22},[480],"PHASE4","Esketamine is frequently used during the perioperative period for supplemental analgesia. Small sample size trials showed that subanesthetic dose esketamine may decrease postoperative neurocognitive complications. However, conflicting results exist and optimal dose of esketamine remains to be determined. This dose-exploring pilot trial is designed to evaluate the safety and efficacy of three different perioperative esketamine dosing regimens in older patients undergoing major non-cardiac surgery. The primary purpose is to explore the optimal dosing strategy that produce maximal neurocognitive benefits with minimal adverse neuropsychiatric symptoms.",[483,484,31,32,485],"Elderly","Noncardiac Surgery","Esketamine",[487,488,36,37,485],"Older patients","Noncardiac surgery","2026-04-09",{"date":491,"type":42},"2026-04-14",{"date":493,"type":22},"2026-04",{"date":495,"type":22},"2026-12",{"name":48,"class":49},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":4},"100614200","verification-of-a-new-predictive-delirium-score-in-adults-with-elective-cardiac-valve-or-bypass-surgery-with-perioperative-use-of-a-heart-lung-machine-a-monocentric-pilot-observational-study-100614200","NCT07276503","Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study","Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery","MO-FA2-(TB)","Inclusion Criteria:\n\n* Elective cardiac surgery Heart valve surgery, bypass surgery with CPB\n* Length of stay in ICU \\> 48 hours\n* Age ≥18 years\n* Fluent German language skills\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Lack of capacity to give consent\n* Emergency\n* Readmission to intensive care unit\n* OPCAB surgery, microsurgical procedure",{"count":506,"type":22},100,"Basics (state of scientific knowledge):\n\nDelirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers.\n\nIn cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis.\n\nBoth current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium.\n\nObjectives of the study:\n\nVerification of the predictive score \"MO-FA2-(TB)\" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints\n\nCategories examined in the score:\n\nMemory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time\n\nStudy duration (for individual subjects):\n\npostoperative intensive care stay up to and including day 10\n\nStudy population Patients who have to undergo cardiac surgery with CPB\n\nInclusion criteria:\n\nElective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU \\> 48 hours Age ≥18 years Fluent German language skills\n\nExclusion criteria:\n\nAge \\\u003C18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure\n\nRecruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay \\>48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10\n\nTreatment data collected:\n\nPreoperative data, including ejection fraction, aids, abuse, scores collected (\"4AT test\" for rapid assessment of delirium and cognitive impairment, \"MO-FA2-(TB)\", \"geriatric check\" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis\n\nNumber of cases: Approx. 100 patients\n\nMethodology Monocentric, observation",[509,32],"Emergence Delirium",[511,512,513,514,515,516,503],"predicitve","delirium","postoperative","valve surgery","bypass surgery","Score","2026-03-05",{"date":519,"type":42},"2026-03-06",{"date":521,"type":22},"2026-03-09",{"date":523,"type":22},"2028-05-30",{"name":525,"class":49},"University Hospital Tuebingen",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":50},"100442065","decreasing-preoperative-stress-to-prevent-postoperative-delirium-and-postoperative-cognitive-decline-in-cardiac-surgical-patients-100442065","NCT05036538","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients.","Decreasing Preoperative Stress to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Relaxation Interventions Via Virtual Reality and Binaural Beats.","DESTRESS-SURG","Inclusion Criteria:\n\n1. Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement\u002Freconstruction, or combination surgery) with standardized extracorporeal circulation.\n2. A sufficiently good knowledge of German is necessary as neuropsychological tests are language-dependent.\n\nExclusion Criteria:\n\n1. History of acute clinically relevant cognitive impairment of any cause (e.g., dementia, depression, stroke, multiple sclerosis) that may impair neuropsychological evaluation.\n2. Contraindications to the presentation of binaural beats or visual stimuli (e.g., epilepsy),\n3. Significant hearing loss or astigmatism, which may interfere with optimal perception of auditory and visual stimuli.\n4. Taking sedatives on the day of surgery.\n5. Unwilling to participate in the relaxation procedure or neuropsychological testing due to deteriorating health, lack of motivation, or other reasons.\n6. Participation in interventions that aim to change cognitive or emotional functioning which cannot be systematically controlled by our study team.\n7. Participation in an interventional study according to AMG\u002FMPG will also be excluded.\n8. Patients with missing informed consent.",{"count":535,"type":22},125,[25],"Patients undergoing cardiac surgery often complain of anxiety before a major operation and the resulting stress. This circumstance is a risk factor for mental problems that may occur after the operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.",[539,140,32],"Preoperative Stress",[226,541,32,539,542,543,544],"Postoperative Cognitive Decline","Relaxation Intervention","Virtual Reality","Binaural Beats","2026-02-13",{"date":547,"type":42},"2026-02-17",{"date":549,"type":42},"2023-07-27",{"date":551,"type":22},"2028-11",{"name":553,"class":49},"Heart and Brain Research Group, Germany",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":50},"100400420","increasing-preoperative-cognitive-reserve-to-prevent-postoperative-cognitive-dysfunction-in-cardiac-surgical-patients-100400420","NCT04493996","Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients","Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training","INCORE","Inclusion Criteria:\n\n* Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement\u002Freconstruction, or combination surgery) with standardized extracorporeal circulation\n* A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent\n\nExclusion Criteria:\n\n* History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance",{"count":506,"type":22},[25],"Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.",[541,32,140],[226,541,32,567,568,140],"Cognitive Training","Cognitive Reserve",{"date":547,"type":42},{"date":571,"type":42},"2020-08-14",{"date":573,"type":22},"2026-03",{"name":553,"class":49},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":87,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":602,"locationsCount":4},"100623634","effect-of-perioperative-iv-ibuprofen-on-cerebral-oxygenation-and-postoperative-cognition-during-one-lung-ventilation-100623634","NCT07399184","Effect of Perioperative IV Ibuprofen on Cerebral Oxygenation and Postoperative Cognition During One-Lung Ventilation","Comparison of the Effects of Ibuprofen on Cerebral Oxygenation, Postoperative Cognitive Dysfunction, and Delirium in One-Lung Ventilation","Inclusion Criteria:\n\n* Patients aged 18-75 years\n* American Society of Anesthesiologists (ASA) Physical Status Classification System I-III\n* Patients scheduled for lobectomy or segmentectomy via Video-Assisted Thoracic Surgery (VATS ) with one-lung ventilation\n* New York Heart Association (NYHA) class I-II\n* Patients who have been informed about the study and have provided written informed consent will be included.\n\nExclusion Criteria:\n\n* Patients younger than 18 years or older than 75 years\n* History of alcohol or substance abuse\n* Patients with chronic NSAID use and\u002For NSAID use within the last 30 days, or NSAID allergy\n* Allergy to other drugs used in the study (e.g., bupivacaine)\n* ASA Physical Status IV-V\n* Severe hearing, visual, or speech impairment\n* Dementia, Alzheimer's disease, or psychiatric disorders (psychosis, bipolar disorder, schizophrenia)\n* History of previous head trauma\n* Chronic liver disease\n* Pregnancy\n* History of cerebrovascular disease\n* Moderate-to-severe chronic obstructive pulmonary disease (COPD) (predicted FEV₁ \\\u003C50%)\n* GFR \\\u003C60 mL\u002Fmin\u002F1.73 m²\n* Patients who do not provide written informed consent\n* Conditions that may cause inaccurate cerebral oximetry readings (subdural and\u002For extracranial hematoma, intracranial arteriovenous shunts, hyperbilirubinemia)\n* Patients undergoing emergency surgery\n* Patients in whom surgery is initiated as thoracotomy or converted to thoracotomy\n* Patients unable to complete the preoperative MMSE (total score ≤24) will be excluded.","75 Years",{"count":584,"type":22},54,[25],"This study compares the effects of ibuprofen administered during surgery and within the first 24 hours after surgery, versus no ibuprofen, on cerebral oxygenation, postoperative changes in consciousness (postoperative delirium and cognitive dysfunction), length of stay in the intensive care unit, and the incidence of postoperative pain, nausea, vomiting, and pruritus in patients undergoing lung lobectomy or segmentectomy using a closed (video-assisted) method (VATS - video-assisted thoracoscopic surgery), in whom one-lung ventilation is applied.\n\nThe aim of this study is to evaluate the effects of ibuprofen on cerebral oxygenation, postoperative cognitive changes, and delirium in patients undergoing one-lung ventilation.",[32,588,589],"Cerebral Oxygen Saturation","Postoperative Cognitive Dysfunction (POCD)",[591,592,593,118,594,595],"cerebral oxygenation","near infrared spectroscopy","thoracic anesthesia","one lung ventilation","ibuprofen","2026-02-08",{"date":598,"type":42},"2026-02-10",{"date":600,"type":22},"2026-02-15",{"date":75,"type":22},{"name":603,"class":49},"Ondokuz Mayıs University",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":4},"100621349","association-of-preoperative-hippocampal-glucose-metabolism-with-postoperative-delirium-in-older-diabetic-patients-100621349","NCT07369466","Association of Preoperative Hippocampal Glucose Metabolism With Postoperative Delirium in Older Diabetic Patients","Preoperative Hippocampal Glucose Metabolism Levels and the Risk of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Diagnosed with type 2 diabetes mellitus (T2DM).\n2. Age ≥ 65 years.\n3. Scheduled for elective liver tumor resection surgery with an expected operative duration \\> 2 hours.\n4. Underwent whole-body ¹⁸F-FDG PET\u002FCT scan within 1 month prior to surgery.\n\nExclusion Criteria:\n\n1. Patient declines to participate.\n2. Inability to cooperate with cognitive assessments or a preoperative Mini-Mental State Examination (MMSE) score \\\u003C 23.\n3. American Society of Anesthesiologists (ASA) physical status classification ≥ IV.\n4. History of organic brain disorders, including stroke, traumatic brain injury, or intracranial tumors.\n5. History of psychiatric disorders or current use of antipsychotic medications.",{"count":612,"type":22},154,"Objective: To investigate the association between preoperative hippocampal glucose metabolism levels and the risk of postoperative delirium (POD) in elderly patients with type 2 diabetes (T2DM), and to provide a prospective neuroimaging biomarker for identifying high-risk populations.\n\nMethods: This prospective cohort study plans to enroll 154 elderly T2DM patients scheduled for liver tumor resection at the First Medical Center of Chinese PLA General Hospital. Baseline cognitive function will be assessed using the Mini-Mental State Examination (MMSE) one day before surgery. Hippocampal glucose metabolism will be quantitatively evaluated by measuring the mean standardized uptake value (SUVmean) of bilateral hippocampi using ¹⁸F-FDG PET\u002FCT. POD will be assessed twice daily from postoperative days 1 to 7 using the 3-Minute Diagnostic Interview for CAM (3D-CAM). The correlation between preoperative hippocampal SUVmean and POD incidence will be analyzed using univariate and multivariate logistic regression models. The predictive performance will be evaluated by constructing receiver operating characteristic (ROC) curves. Furthermore, the relationship between a peripheral insulin resistance marker (the triglyceride-glucose index, TyG index) and hippocampal metabolism levels will be analyzed.\n\nSignificance: This study aims to determine whether impaired preoperative hippocampal metabolism serves as an independent risk factor for POD. The findings are expected to provide a prospective functional neuroimaging biomarker for the early warning of POD and offer a theoretical basis for developing precise prevention strategies targeting cerebral metabolic abnormalities. This will facilitate the application of neuroimaging techniques in the field of perioperative brain dysfunction monitoring.",[32,615],"Type 2 Diabetes",[37,617,618,619,620],"Type 2 Diabetes Mellitus","Positron-Emission Tomography","Hippocampus","Glucose metabolism","2026-01-18",{"date":623,"type":42},"2026-01-27",{"date":625,"type":22},"2026-02-01",{"date":627,"type":22},"2028-06-01",{"name":629,"class":49},"Chinese PLA General Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":4,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":637,"enrollmentInfo":638,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":644,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":656,"locationsCount":50},"100619965","remimazolam-for-reducing-postoperative-delirium-in-elderly-patients-undergoing-laparoscopic-gastrectomy-100619965","NCT07351474","Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy","Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 65 years.\n* Body mass index (BMI) between 18 and 28 kg\u002Fm².\n* ASA physical status I-III.\n* Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.\n* Able and willing to sign informed consent.\n\nExclusion Criteria:\n\n* Severe respiratory, cardiovascular, renal, or hepatic dysfunction.\n* Stroke within the past 6 months or other central nervous system diseases.\n* History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.\n* History of alcohol abuse or psychoactive substance dependence.\n* Severe visual, hearing, or language impairment preventing communication.\n* Allergy or contraindication to propofol or benzodiazepines.\n* Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).\n* Participation in another drug clinical trial within 1 month before surgery.","100 Years",{"count":639,"type":22},170,[25],"This prospective, randomized controlled clinical trial aims to evaluate whether remimazolam can reduce the incidence of postoperative delirium (POD) in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer. A total of 170 patients aged 65 years or older will be enrolled and randomized in a 1:1 ratio to receive either remimazolam or a propofol-midazolam regimen for anesthesia induction and maintenance. Standard perioperative monitoring, BIS-guided anesthesia depth control, and postoperative pain management will be applied in both groups. The primary outcome is the incidence of postoperative delirium within 5 days after surgery, assessed twice daily using the 3D-CAM. Secondary outcomes include emergence agitation, extubation time, postoperative pain scores, cognitive function at discharge, intraoperative hemodynamic stability, unplanned ICU admission, postoperative complications, and length of ICU stay. This study aims to determine whether remimazolam provides a safer and more effective anesthetic option for improving postoperative neurological outcomes and recovery in elderly patients undergoing laparoscopic radical gastrectomy.",[643,32],"Gastric Cancer",[645,646,647,648,649,32],"Remimazolam","Propofol","Elderly Patients","Laparoscopic Gastrectomy","Anesthesia","2026-01-16",{"date":652,"type":42},"2026-01-20",{"date":654,"type":22},"2026-01-01",{"date":448,"type":22},{"name":657,"class":49},"The First Affiliated Hospital with Nanjing Medical University",{"id":659,"slug":660,"hasResults":12,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":4,"eligibilityCriteria":664,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":665,"targetDuration":4,"studyType":23,"phases":667,"briefSummary":668,"conditions":669,"keywords":670,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":50},"100609694","phase-2-daridorexant-to-prevent-post-cardiotomy-delirium-100609694","NCT07217912","Daridorexant to Prevent Post-cardiotomy Delirium","Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery","Inclusion Criteria:\n\n* ≥ 60 yrs;\n* having surgical aortic valve surgery or coronary artery bypass graft surgery at Strong Memorial Hospital;\n* can provide consent;\n* able to speak, read,and write English (as the instruments, including semi-structured interviews, used in this protocol have been validated in English);\n* family member or close friend for collateral.\n\nExclusion Criteria:\n\n* Prior cardiotomy\n* Infectious endocarditis\n* Emergency surgery\n* Delirium at baseline (positive 3D-CAM)\n* Auditory or visual impairment that prevents study procedures\n* Alcohol or substance misuse (CAGE-AID score ≥ 2)\n* Psychotic disorder\n* Dementia-level deficits (TICS \\\u003C 27)\n* Use of a prescription sleep aid at least every other night\n* Use of a strong CYP3A4 inhibitor (e.g., ceritinib, clarithromycin, cobicistat, idelalisib, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, voriconazole)\n* Daridorexant intolerance\n* Severe kidney or liver impairment (Child-Pugh ≥7, Cockcroft-Gault \\\u003C30 mL\u002Fmin, or on dialysis)\n* Narcolepsy\n* Suicidal ideation at baseline\n* Any condition that, in the PI's opinion, compromises patient safety or data quality\n* Additional exclusions for the NLP exploratory aim: history of traumatic brain injury or head concussions with loss of consciousness, use of corticosteroids, or history of major neurological disease or brain surgery",{"count":666,"type":22},80,[163],"The goal of this follow-on pilot randomized clinical trial is to obtain additional preliminary data to inform a larger, adequately powered phase 2b trial of daridorexant for the prevention of postoperative delirium after heart surgery. Having demonstrated feasibility in a prior study (RSRB #9841), this study aims to estimate the effect of daridorexant on (1) reducing delirium symptom burden and incidence and (2) improving self-reported sleep quality during the postoperative period, and (3) to assess the feasibility of collecting objective sleep data in the postoperative setting.\n\nParticipants will: complete a baseline visit; take the study drug, either daridorexant or placebo, each of the first three nights after heart surgery; and be evaluated daily for sleep and delirium during the first three postoperative days. Participants will also have the option of wearing a sleep monitor in the hospital each of the first three nights after surgery.",[541,32],[512,671,672,673],"sleep","cognitive decline","Alzheimer disease and related dementias","2026-01-06",{"date":676,"type":42},"2026-01-07",{"date":678,"type":42},"2025-10-14",{"date":680,"type":22},"2027-11-01",{"name":682,"class":49},"University of Rochester"]