[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"procedural-sedation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:procedural-sedation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,81,111,147],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100651704","therapeutic-effects-of-music-on-procedural-outcomes-100651704",false,"NCT07763860","Therapeutic Effects of Music on Procedural Outcomes","Effect of Intra-Procedural Low-Tempo Instrumental Music Plus Standard Sedation Versus Standard Sedation Alone on Sedative Requirements in Adults Undergoing Gastroscopy and\u002For Colonoscopy: a Single-Center, Parallel-Group, Randomized Superiority Trial With Blinded Outcome Assessors and Statisticians","TEMPO","Inclusion Criteria:\n\n* Age ≥18 years.\n* Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency or urgent endoscopic procedure.\n* Hearing impairment that prevents adequate perception of the standardized test audio through the study headphones.\n* American Society of Anesthesiologists (ASA) Physical Status IV or higher.\n* Cognitive impairment, altered mental status, or another condition that prevents provision of informed consent or reliable completion of study assessments.\n* Any condition that prevents safe or appropriate use of the study headphones.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and\u002For colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and\u002For colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music.\n\nThe main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.",[27,28,29],"Procedural Sedation","Gastrointestinal Endoscopy","Music Intervention",[31,32,33,34,27,35,36,37,38,39],"Music","Low-Tempo Music","Gastroscopy","Colonoscopy","Sedation","Propofol","Pain","Patient Satisfaction","Recovery Time","RECRUITING","2026-08-09",{"date":43,"type":44},"2026-08-13","ACTUAL",{"date":46,"type":21},"2026-08",{"date":48,"type":21},"2026-10",{"name":50,"class":51},"Bahaa Bou Dargham","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":52},"100650586","sed-pack-safety-and-performance-of-a-medical-device-software-for-predictive-monitoring-during-sedation-100650586","NCT07749781","SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation","Prospective Observational Clinical Investigation to Evaluate the Clinical Performance and Safety of a Medical Device Software (SED Pack) During Standard Procedural Sedation","Inclusion Criteria:\n\n* Age ≥18 years\n* ASA physical status I-III\n* Scheduled for an elective, non-emergent gastrointestinal endoscopic procedure\n* Procedural sedation planned with propofol and remifentanil administered via a target-controlled infusion (TCI) system\n* Administration of sedative and analgesic drugs via a peripheral venous line\n* Ability to understand the study information and provide written informed consent\n\nExclusion Criteria:\n\n* Presence of medical conditions or use of medications that, in the investigator's judgment, could significantly interfere with the interpretation of physiological signals used as reference standards (e.g., severe autonomic dysfunction, severe movement disorders).\n* Known severe neurologic, cardiovascular or respiratory disease that substantially alters baseline physiological monitoring or expected sedation response\n* ASA physical status IV, V or VI\n* Known or anticipated difficult airway requiring advanced airway management or interfering with standard respiratory monitoring\n* Requirement for central venous access for drug administration\n* Sedation performed outside the endoscopy unit (e.g., intensive care, emergency department)\n* Inability to understand study information, provide consent or cooperate with clinical assessments due to language barrier or cognitive impairment",{"count":61,"type":21},120,"OBSERVATIONAL","The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a fully blinded, non-interventional setting during routine procedural sedation in adult patients at Hospital Clínic de Barcelona, Spain.\n\nProcedural sedation consists in the administration of sedative and analgesic drugs to allow patients to undergo routine diagnostic or therapeutic procedures comfortably. Despite advances in monitoring technology, adverse events such as arterial hypotension, respiratory depression, or inadequate sedation remain frequent due to marked interindividual variability in drug response. Currently, clinicians rely on standard physiological monitoring that measures what is happening in real time but does not anticipate what is about to happen.\n\nSED Pack is designed to address this gap by continuously processing physiological monitoring data and drug-infusion information to generate four real-time predictive indices (updated once per second): pSED (sedation depth), pNOC (likelihood of response to a noxious stimulus), pHYPO (likelihood of arterial hypotension), and pDEP (likelihood of respiratory depression).\n\nIn this clinical investigation, one hundred and twenty adult patients (≥18 years, ASA I-III) will be enrolled. Predictive performance is evaluated using the c-index for pSED, pHYPO, and pDEP, and AUC-ROC for pNOC. The primary hypothesis is that each index achieves a discrimination performance ≥0.70 (lower bound of the 95% CI also ≥0.70). The software runs in fully blinded mode: its predictions are not visible to clinicians and do not influence patient management. No additional procedures beyond standard clinical care are introduced.\n\nThe study complies with MDR 2017\u002F745 and ISO 14155, with AEMPS authorization and CEIm approval (reference: HCB\u002F2026\u002F0307).\n\nExpected outcomes include confirmation that each SED Pack predictive index achieves clinically acceptable discrimination performance, supporting the clinical use of this investigational software as a tool to anticipate and prevent sedation-related complications.",[27,28],[66,67,68,69,70],"Medical device software","Predictheon","Observational","Non-interventional","Predictive monitoring","2026-08-04",{"date":73,"type":44},"2026-08-06",{"date":75,"type":44},"2026-07-23",{"date":77,"type":21},"2026-12",{"name":79,"class":80},"Predictheon Medical, S.L.","INDUSTRY",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":52},"100647997","hfno-versus-face-mask-for-cerebral-oxygenation-during-procedural-sedation-100647997","NCT07718295","HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation","Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* American Society of Anesthesiologists physical status I-IV\n* Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting\n* Ability to provide written informed consent\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Refusal or inability to provide written informed consent\n* Known neurological disorders\n* History of ischemic or hemorrhagic stroke\n* History of traumatic brain injury or previous cranial surgery\n* Peripheral arterial disease or systemic vasculitis\n* Advanced heart failure\n* Uncontrolled hypertension\n* Uncontrolled diabetes mellitus\n* Advanced chronic obstructive pulmonary disease (COPD)\n* Severe anemia (hemoglobin \\\u003C8 g\u002FdL)\n* Skin lesions or other conditions preventing proper placement of NIRS sensors\n* Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy\n* Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results",{"count":89,"type":21},100,[24],"This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness\u002FSedation (MOAA\u002FS) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.",[27,93,94,95],"Hypoxemia","Cerebral Oxygenation","SEDLine",[97,98,99,100,101],"High-flow nasal oxygen (HFNO)","Procedural sedation","Cerebral oxygenation","Near-infrared spectroscopy (NIRS)","Patient State Index (PSI)","2026-07-16",{"date":104,"type":44},"2026-07-21",{"date":106,"type":44},"2026-06-01",{"date":108,"type":21},"2026-12-31",{"name":110,"class":51},"Firat University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":128,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":52},"100611048","anesthesia-management-in-endovascular-therapy-for-ischemic-stroke---2-100611048","NCT07235514","Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2","General Anesthesia Versus Procedural Sedation in Endovascular Therapy for Anterior Circulation Large Vessel Occlusion Stroke: A Multicenter Prospective Randomized Trial","AMETIS 2","Inclusion Criteria:\n\n* Age ≥18 years\n* Acute ischemic stroke with an occlusion of the intracranial internal carotid artery and\u002For the proximal middle cerebral artery (M1-M2) with or without association of extracranial occlusion of the cervical internal carotid artery (tandem lesion)\n* Eligible for mechanical thrombectomy according to international guidelines\n* Informed and signed consent of patient, or if he is unable to consent the consent of patient's relative or emergency procedure in the absence of relative\n* National health insurance\n\nExclusion Criteria:\n\n* Coma or altered vigilance defined as a score ≥ 2 on the level of consciousness 1A subscale of the NIHSS\n* Premorbid disability defined as a mRS \\> 2\n* Posterior circulation stroke\n* Associated cerebral hemorrhage\n* Stroke complicating another acute illness or postoperative stroke\n* Emesis at arrival in angiosuite\n* Allergy to anesthetic medication\n* Pregnant or breast-feeding women\n* Adult under the protection of the law",{"count":120,"type":21},958,[24],"The goal of this clinical trial is to learn what is the best anesthetic management in participants with severe stroke that require a medical intervention called mechanical thrombectomy (MT) done to open the occluded brain vessel.\n\nThe main question it aims to answer is:\n\n• Is general anesthesia (GA) better than procedural sedation (PS) for improving functional performance and decrease dependance in daily life 3 months after stroke?\n\nGA (a non-arousable state induced by anesthetic medications that require respiratory assistance) or PS (a state of reduced arousal induced by lesser dose of anesthetic medications that do not require respiratory assistance) are both used for MT. GA enables strict immobility that could facilitate the conduct of MT but lessen blood pressure and blood flow in the brain. PS provides less drop in blood pressure but MT could be more difficult due to possible movement and breathing may be decreased.\n\nResearchers will compare GA with PS to see which one is better for MT success and for the functional consequences of stroke.\n\nParticipants will be treated with GA or PS for the intervention of MT and will be followed by researchers during their hospital stay and asked by a telephone interview how is their functional status 3 months after stroke.",[124,125,126,27,127],"Ischemic Stroke","Anterior Cerebral Circulation","General Anesthesia","Thrombectomy",[129,130,131,132,133,134,135,136],"Ischemic stroke","anterior circulation","mechanical thrombectomy","anesthetic strategy","general anesthesia","procedural sedation","functional outcome","large vessel occlusion stroke","NOT_YET_RECRUITING","2025-11-17",{"date":140,"type":44},"2025-11-19",{"date":142,"type":21},"2025-12-01",{"date":144,"type":21},"2029-03-01",{"name":146,"class":51},"University Hospital, Clermont-Ferrand",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":52},"100609358","phase-4-remimazolam-vs-propofol-in-laser-burn-cases-100609358","NCT07213544","Remimazolam vs Propofol in Laser Burn Cases","Comparison of Remimazolam Versus Propofol for Monitored Anesthetic Care in Elective Fractional Ablative CO₂ Laser","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing both outpatient Session #1 and Session #2 of fractional ablative CO2 laser therapy\n\nExclusion Criteria:\n\n* History of previous fractional ablative laser therapy for burn scar\n* Procedure expected to last longer than 30 minutes\n* Allergy such as dextran 40 or contraindication to either of the study drugs\n* Pregnant and\u002For breastfeeding\n* Subjects who are unable to or choose not to give informed consent",{"count":155,"type":21},136,[157],"PHASE4","This randomized, single-blind, crossover study compares remimazolam and propofol for monitored anesthetic care during fractional ablative CO₂ laser therapy for burn scars. The primary aim is to assess incidence of respiratory depression, defined as a need for advanced airway maneuvers (jaw thrust\u002Fchin lift, insertion of oral or nasal airway, or bag mask ventilation), and hypopnea (respiratory rate \\\u003C 8).",[160,161,27],"Burn Scar","Hypertrophic Scarring",{"date":163,"type":44},"2025-11-20",{"date":165,"type":44},"2025-11-12",{"date":167,"type":21},"2027-01-01",{"name":169,"class":51},"Medical University of South Carolina"]