[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620427":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":75,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":25,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Manual Total Intravenous Anesthesia","EXPERIMENTAL","Participants receive manually controlled total intravenous anesthesia using propofol and remifentanil, with dosing adjusted by the anesthesiologist based on clinical parameters and bispectral index monitoring.",[13],"Device: Total Intravenous Anesthesia(TIVA)",{"label":15,"type":10,"description":16,"interventionNames":17},"Target-Controlled Infusion (TCI)","Participants receive target-controlled infusion of propofol and remifentanil using the Eleveld pharmacokinetic model, with effect-site targeting throughout the surgical procedure.",[18],"Device: Target Controlled Infusion",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Target Controlled Infusion","Total Intravenous Anesthesia (TIVA) will be administered using an infusion pump (e.g., BeneFusion nSP) equipped with the Eleveld pharmacokinetic model. Propofol will be initiated at a target concentration of 3-3.5 µg\u002Fml, and Remifentanil at 2-3 ng\u002Fml (effect-site targeting). The \"opioid present\" option will be selected for the propofol model. Doses will be titrated to maintain a Bispectral Index (BIS) value between 40-60 throughout the surgery.",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Total Intravenous Anesthesia(TIVA)","Total Intravenous Anesthesia (TIVA) will be administered via manual titration. Induction will be performed with 20 mg propofol boluses based on EEG changes on the BIS monitor, followed by a remifentanil infusion of 0.1 µg\u002Fkg\u002Fmin. Maintenance doses will be manually adjusted by the anesthesiologist to maintain a Bispectral Index (BIS) value between 40-60 and hemodynamic stability.",[9],[31],"Manually controlled Total Intravenous Anesthesia",[33],{"name":34,"affiliation":35,"role":36},"Ali Okuyan, MD","İstanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":25,"email":41},"CONTACT","+905073736874","aliokuyan@gmail.com",[43,65],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":25,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine","NOT_YET_RECRUITING","Istanbul","Bakırköy","34153","Turkey (Türkiye)",{"type":51,"coordinates":52},"Point",[53,54],28.94966,41.01384,{"lat":54,"lon":53},[57,59,60,63],{"name":34,"role":39,"phone":40,"phoneExt":25,"email":58},"aliokuyan96@gmail.com",{"name":34,"role":36,"phone":25,"phoneExt":25,"email":25},{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Eren Fatma Akçıl, MD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":25,"phoneExt":25,"email":25},"Özlem Korkmaz Dilmen, MD",{"facility":66,"status":67,"city":46,"state":46,"zip":48,"country":49,"countryCode":25,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Cerrahpaşa Tıp Fakültesi Murat Dilmener Hastanesi","RECRUITING",{"type":51,"coordinates":69},[53,54],{"lat":54,"lon":53},[72],{"name":73,"role":39,"phone":40,"phoneExt":25,"email":74},"Ali Okuyan","Aliokuyan96@gmail.com",{"type":36,"investigatorFullName":73,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Research Assistant, Department of Anesthesiology and Reanimation","100620427","comparison-of-target-controlled-and-manual-total-intravenous-anesthesia-in-supratentorial-surgery-100620427",false,"NCT07357480","Comparison of Target-Controlled and Manual Total Intravenous Anesthesia in Supratentorial Surgery","Comparison of Target-Controlled Infusion Using the Eleveld Model and Manual Total Intravenous Anesthesia on Intraoperative Anesthetic Consumption and Postoperative Pain and Delirium in Supratentorial Surgery","Inclusion Criteria:\n\n* Adult patients aged 18 to 60 years\n* Scheduled for elective supratentorial surgery under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Planned total intravenous anesthesia with propofol and remifentanil\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Refusal or inability to provide written informed consent\n* American Society of Anesthesiologists (ASA) physical status III or higher\n* Pregnancy\n* Emergency surgery\n* Presence of brain herniation\n* Anticipated or documented difficult airway\n* Inability to communicate effectively (e.g., non-Turkish speaking or hearing impairment)\n* Preoperative risk factors for delirium, including substance abuse, use of neuropsychiatric medications, preoperative hemoglobin level \\\u003C 8 g\u002FdL, malnutrition, or electrolyte or thyroid hormone abnormalities\n* Intraoperative deviation from the study protocol, including changes in surgical or anesthetic technique or occurrence of major intraoperative complications\n* Contraindications to propofol or remifentanil","ALL","18 Years","60 Years",{"count":88,"type":89},70,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study aims to investigate the effect of target-controlled infusion using the Eleveld pharmacokinetic model compared with manually controlled total intravenous anesthesia on the incidence of postoperative delirium in patients undergoing supratentorial surgery. Propofol and remifentanil are administered using either target-controlled or manual infusion techniques according to the study protocol. Secondary objectives include comparisons of intraoperative anesthetic consumption, hemodynamic responses, recovery profiles, postoperative pain, and postoperative nausea and vomiting between the two anesthesia strategies. The study seeks to evaluate whether target-controlled infusion provides improved anesthetic management and postoperative outcomes compared with manual total intravenous anesthesia.",[95,96,97,98,99],"Postoperative Delirium (POD)","Postoperative Pain","PONV","Burst Suppression","Recovery Period, Anesthesia",[22,101,102,103,104,105,106,107],"Total Intravenous Anesthesia","Eleveld Model","Postoperative Delirium","Supratentorial Surgery","Bispectral Index","Propofol","Remifentanil","2026-03-24",{"date":110,"type":111},"2026-03-25","ACTUAL",{"date":113,"type":111},"2026-01-14",{"date":115,"type":89},"2026-05",{"name":5,"class":6},2]