[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658941":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":41,"overallOfficials":51,"centralContacts":55,"locations":64,"responsibleParty":88,"collaborators":28,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":28,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":28,"enrollmentInfo":101,"targetDuration":28,"studyType":104,"phases":28,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":67,"whyStopped":28,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in Serum Melatonin Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status","Serum melatonin concentration will be measured preoperatively and on postoperative day 3. For each participant, the change in melatonin concentration will be calculated as the postoperative day 3 value minus the preoperative value and reported in pg\u002FmL. Participants will be classified as having postoperative delirium if at least one CAM assessment on postoperative days 1, 3, or 5 is positive. The change in melatonin concentration will be compared between participants with and without postoperative delirium.","Preoperative baseline to postoperative day 3; postoperative delirium status assessed through postoperative day 5",{"measure":14,"description":15,"timeFrame":16},"Number of Participants With Postoperative Delirium Assessed by the Confusion Assessment Method","Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) on postoperative days 1, 3, and 5. A participant will be classified as having postoperative delirium if any of these postoperative CAM assessments is positive. According to the CAM algorithm, delirium is present when acute onset and fluctuating course and inattention are present together with either disorganized thinking or an altered level of consciousness. The number and percentage of participants with postoperative delirium will be reported.","Postoperative day 1 through postoperative day 5",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"Change in Serum Serotonin Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status","Serum serotonin concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.","Preoperative baseline to postoperative day 3",{"measure":23,"description":24,"timeFrame":21},"Change in Serum Kynurenine Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status","Serum kynurenine concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.",{"measure":26,"description":27,"timeFrame":21},"Change in Serum Kynurenic Acid Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status","Serum kynurenic acid concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","Postoperative delirium is an acute neurocognitive disorder that occurs frequently in older patients after major surgery. Neuroinflammation, alterations in neurotransmitter metabolism, oxidative stress, and disruption of circadian rhythm have been proposed as contributing mechanisms.\n\nThe primary objective of this prospective observational cohort study is to evaluate the relationship between perioperative endogenous melatonin levels and the development of postoperative delirium in patients aged 65 years or older undergoing elective abdominal surgery for malignancy. Secondary objectives include evaluation of serotonin, kynurenine, kynurenic acid, and vitamin B12 levels in relation to postoperative delirium.\n\nEligible participants will receive the routine standardized anesthesia and analgesia protocol used at the study center, including general anesthesia and thoracic epidural analgesia. No experimental drug or treatment will be administered.\n\nVenous blood samples will be obtained during the preoperative period for measurement of melatonin, serotonin, kynurenine, kynurenic acid, and vitamin B12. These biomarkers will be measured again on postoperative day 3. In participants who develop postoperative delirium, an additional sample will be obtained as soon as possible after delirium is detected.\n\nIntraoperative hemodynamic parameters, vasopressor requirements, cerebral oxygenation measured by near-infrared spectroscopy, depth of anesthesia measured by Bispectral Index, estimated blood loss, blood product transfusion, anesthesia duration, and surgical duration will also be recorded.\n\nPostoperative delirium will be prospectively evaluated using the Confusion Assessment Method on postoperative days 1, 3, and 5. Participants will subsequently be classified as having or not having postoperative delirium, and perioperative biomarker levels and clinical variables will be compared between these groups.","The study population will consist of patients aged 65 years or older who are scheduled for elective abdominal surgery for malignancy at Bakirkoy Dr. Sadi Konuk Research and Training Hospital and who meet the study eligibility criteria and provide written informed consent.",[35],{"label":36,"type":28,"description":37,"interventionNames":38},"Older Adults Undergoing Elective Abdominal Cancer Surgery","Patients aged 65 years or older undergoing elective abdominal surgery for malignancy under general anesthesia with thoracic epidural analgesia. All participants will be prospectively followed for postoperative delirium through postoperative day 5. Participants will not be assigned to treatment groups. For analysis, participants will be classified according to whether postoperative delirium develops based on CAM assessments.",[39,40],"Diagnostic Test: Perioperative Biomarker Assessment","Diagnostic Test: Confusion Assessment Method (CAM)",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":28},"DIAGNOSTIC_TEST","Perioperative Biomarker Assessment","Venous blood samples will be obtained preoperatively and on postoperative day 3 for measurement of melatonin, serotonin, kynurenine, kynurenic acid, and vitamin B12. In participants who develop postoperative delirium, an additional blood sample will be obtained as soon as possible after delirium is detected. Biomarker measurements will not be used to determine clinical treatment.",[36],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":28},"Confusion Assessment Method (CAM)","The Confusion Assessment Method will be used to assess delirium preoperatively and on postoperative days 1, 3, and 5. Postoperative delirium will be considered present if at least one postoperative CAM assessment is positive.",[36],[52],{"name":53,"affiliation":5,"role":54},"Fatma Çiğdem Özakın, MD","STUDY_DIRECTOR",[56,61],{"name":57,"role":58,"phone":59,"phoneExt":28,"email":60},"Fidan Aygün, MD","CONTACT","+90 505 400 2965","fidanaygun1971@gmail.com",{"name":53,"role":58,"phone":62,"phoneExt":28,"email":63},"+90 546 416 82 50","f.cigdemulus@gmail.com",[65],{"facility":66,"status":67,"city":68,"state":68,"zip":69,"country":70,"countryCode":28,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Bakırköy Dr. Sadi Konuk Training and Research Hospital","RECRUITING","Istanbul","34147","Turkey (Türkiye)",{"type":72,"coordinates":73},"Point",[74,75],28.94966,41.01384,{"lat":75,"lon":74},[78,80,82,84,86],{"name":53,"role":58,"phone":79,"phoneExt":28,"email":63},"+905464168250",{"name":57,"role":81,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":53,"role":83,"phone":28,"phoneExt":28,"email":28},"SUB_INVESTIGATOR",{"name":85,"role":83,"phone":28,"phoneExt":28,"email":28},"Nilgün Işıksaçan, MD",{"name":87,"role":83,"phone":28,"phoneExt":28,"email":28},"Mustafa Yaman, PhD",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Fatma Cigdem Ozakin","MD","100658941","perioperative-biomarkers-and-postoperative-delirium-in-older-adults-undergoing-abdominal-cancer-surgery-100658941",false,"NCT07859488","Perioperative Biomarkers and Postoperative Delirium in Older Adults Undergoing Abdominal Cancer Surgery","Perioperative Melatonin and Other Neuroinflammatory Biomarkers for Predicting Postoperative Delirium in Older Adults Undergoing Elective Abdominal Cancer Surgery","Inclusion Criteria:\n\n* Age 65 years or older.\n* Scheduled for elective abdominal surgery for malignancy.\n* American Society of Anesthesiologists (ASA) physical status II or III.\n* Surgery planned under general anesthesia.\n* Eligible for thoracic epidural analgesia without contraindications to epidural catheter placement.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Preoperative dementia, Alzheimer disease, Parkinson disease, other known neurodegenerative disease, or a history of preoperative cognitive impairment.\n* Emergency surgery.\n* Contraindication to epidural analgesia or refusal of epidural catheter placement.\n* Chronic use of corticosteroids, melatonin preparations, or medications affecting the serotonergic system, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants.\n* Parenteral or high-dose oral vitamin B12 treatment within the previous 3 months.\n* Diagnosis of pernicious anemia.\n* Communication impairment preventing delirium assessment.\n* Advanced liver or kidney failure.\n* Intraoperative mean arterial pressure below 65 mmHg.\n* Surgical duration longer than 240 minutes.\n* Refusal to participate in the study.","ALL","65 Years",{"count":102,"type":103},100,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study aims to investigate the relationship between perioperative endogenous melatonin levels and postoperative delirium in patients aged 65 years or older undergoing elective abdominal cancer surgery. The study will also evaluate serotonin, kynurenine, kynurenic acid, and vitamin B12 as potential biomarkers associated with postoperative delirium.\n\nParticipants will undergo routine standardized general anesthesia and thoracic epidural analgesia. Venous blood samples will be obtained preoperatively and on postoperative day 3. In participants who develop delirium, an additional blood sample will be obtained as soon as possible after delirium is detected. Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) on postoperative days 1, 3, and 5. No experimental drug or additional therapeutic intervention will be administered as part of the study.",[107,108],"Postoperative Delirium (POD)","Abdominal Neoplasms",[110,111,112,113,114,115,116,117,118,119],"Postoperative delirium","Melatonin","Serotonin","Kynurenine","Kynurenic acid","Vitamin B12","Neuroinflammation","Geriatric surgery","Abdominal cancer surgery","Confusion Assessment Method","2026-09-30",{"date":122,"type":123},"2026-10-05","ACTUAL",{"date":125,"type":123},"2026-09-01",{"date":127,"type":103},"2027-09-06",{"name":90,"class":6},1]