[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655071":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":26,"studyPopulation":26,"armGroups":82,"interventions":94,"overallOfficials":26,"centralContacts":104,"locations":110,"responsibleParty":124,"collaborators":26,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":26,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":26,"enrollmentInfo":136,"targetDuration":26,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":148,"overallStatus":158,"whyStopped":26,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Time-weighted average (TWA) of the vasoactive-inotropic score (VIS)","Time-weighted average (TWA) of the vasoactive-inotropic score (VIS), calculated from the start of anesthetic administration to the start of hemostasis at the femoral access site. VIS reflects the cumulative dose of vasoactive and inotropic agents used to maintain target blood pressure during the procedure.","From the start of anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Cumulative norepinephrine dosage","Cumulative norepinephrine dosage including bolus dose",{"measure":18,"description":19,"timeFrame":12},"Peak VIS","Maximum VIS value recorded during the assessment period",{"measure":21,"description":22,"timeFrame":12},"Time-weighted average of cumulative norepinephrine usage","Time-weighted average of cumulative norepinephrine usage including bolus dose",[24,27,29,32,35,37,39,41,43,45,47,50,53,55,58,61,65,68,71],{"measure":25,"description":26,"timeFrame":12},"Time-weighted average patient state index (PSI) during the procedure",null,{"measure":28,"description":26,"timeFrame":12},"Time-weighted average intraoperative mean arterial pressure",{"measure":30,"description":31,"timeFrame":12},"Duration and area under the curve (AUC) out of target mean arterial pressure range","Duration and area under the curve (AUC) out of target mean arterial pressure range (minutes and mmHg·minutes)",{"measure":33,"description":34,"timeFrame":12},"Average amount of remimazolam, propofol, and remifentanil used (mg\u002Fkg\u002Fhr, µg\u002Fkg\u002Fmin, µg\u002Fkg\u002Fmin, respectively)","Average amount of remimazolam, propofol, and remifentanil used (milligrams per kilogram per hour, micrograms per kilogram per minute, and micrograms per kilogram per minute, respectively)",{"measure":36,"description":26,"timeFrame":12},"Incidence and severity of unintended patient movement or spontaneous breathing during general anesthesia (graded as minor, transient surgical interruption, or leading to patient complications)",{"measure":38,"description":26,"timeFrame":12},"Frequency and total dose of bolus administration of vasoactive-inotropic agents (including norepinephrine)",{"measure":40,"description":26,"timeFrame":12},"Time-weighted average usage of vasopressors or inotropes, other than norepinephrine",{"measure":42,"description":26,"timeFrame":12},"Weight-adjusted fluid used (crystalloids and colloids, separately)",{"measure":44,"description":26,"timeFrame":12},"Incidence of blood transfusion, type of blood products, and units transfused",{"measure":46,"description":26,"timeFrame":12},"Incidence of bradycardia (\u003C45 beats per minute) requiring treatment",{"measure":48,"description":26,"timeFrame":49},"Time to loss of consciousness","From the start of anesthetic administration to loss of consciousness (intraoperative, up to 30 minutes)",{"measure":51,"description":26,"timeFrame":52},"Time to reaching Patient State Index (PSI) \u003C=50","From the start of anesthetic administration to the first Patient State Index ≤50 (intraoperative, up to 30 minutes)",{"measure":54,"description":26,"timeFrame":12},"Time to start norepinephrine continuous infusion",{"measure":56,"description":26,"timeFrame":57},"Length of stay in the intensive care unit or recovery room after the procedure","From the end of procedure to ICU\u002Frecovery room discharge, assessed up to 30 days",{"measure":59,"description":26,"timeFrame":60},"Length of hospital stay after the procedure","From the end of procedure to hospital discharge, assessed up to 30 days",{"measure":62,"description":63,"timeFrame":64},"Incidence of postoperative nausea and vomiting (PONV)","Incidence of postoperative nausea and vomiting (PONV), including nausea, vomiting, and requirement for rescue antiemetics, within 24 hours postoperatively","within 24 hours postoperatively",{"measure":66,"description":26,"timeFrame":67},"Time-weighted average QTc (corrected QT) interval and its change from baseline","From the anesthetic administration to the start of femoral access site hemostasis (intraoperative, up to 300 minutes)",{"measure":69,"description":26,"timeFrame":70},"Postoperative opioid consumption, expressed as oral (or intravenous) morphine milligram equivalents (MME)","From the end of procedure to discharge, assessed up to 7 days",{"measure":72,"description":26,"timeFrame":70},"Incidence of postoperative delirium requiring pharmacological management (or clinical intervention)",{"allocation":74,"interventionModel":75,"interventionModelDescription":26,"primaryPurpose":76,"observationalModel":26,"timePerspective":26,"maskingInfo":77},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":78,"maskingDescription":26,"whoMasked":79},"DOUBLE",[80,81],"PARTICIPANT","OUTCOMES_ASSESSOR",[83,89],{"label":84,"type":85,"description":86,"interventionNames":87},"Remimazolam group","EXPERIMENTAL","Remimazolam Besylate (2mg\u002FmL)",[88],"Drug: Remimazolam Besylate",{"label":90,"type":85,"description":91,"interventionNames":92},"Propofol group","Propofol (20mg\u002FmL)",[93],"Drug: propofol",[95,100],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":26},"DRUG","Remimazolam Besylate","* Continuous drug: remimazolam diluted to 2 mg\u002FmL in normal saline\n* Induction: 6 mg\u002Fkg\u002Fh continuous infusion\n* Maintenance: 1-2 mg\u002Fkg\u002Fh (titrated to PSI 25-50, max 2 mg\u002Fkg\u002Fh)\n* Reversal at end of procedure: flumazenil 0.2-0.5 mg",[84],{"type":96,"name":101,"description":102,"armGroupLabels":103,"otherNames":26},"propofol","* Continuous drug: propofol (undiluted, 20 mg\u002FmL)\n* Administration: target-controlled infusion (TCI, Marsh model)\n* Induction: effect-site target concentration 4 μg\u002FmL\n* Maintenance: 2-4 μg\u002FmL (titrated to PSI 25-50)",[90],[105],{"name":106,"role":107,"phone":108,"phoneExt":26,"email":109},"Youn Joung Cho, MD, PhD","CONTACT","82-2-2072-2467","mingming7@gmail.com",[111],{"facility":5,"status":26,"city":112,"state":26,"zip":113,"country":114,"countryCode":26,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"Seoul","03080","South Korea",{"type":116,"coordinates":117},"Point",[118,119],126.9784,37.566,{"lat":119,"lon":118},[122],{"name":106,"role":107,"phone":123,"phoneExt":26,"email":109},"82-2-2072-3108",{"type":125,"investigatorFullName":106,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Clinical Associate Professor","100655071","phase-4-effect-of-remimazolam-versus-propofol-total-intravenous-anesthesia-on-intraoperative-hemodynamic-stability-in-patients-undergoing-thoracic-or-abdominal-endovascular-aortic-repair-100655071",false,"NCT07806006","Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair","Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair: A Randomized, Single-blind, Controlled Clinical Trial","Inclusion Criteria:\n\n\\- Adults aged 20 years or older scheduled for thoracic or abdominal endovascular aortic repair (TEVAR\u002FEVAR) under general anesthesia for thoracic or abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* Known or suspected allergy or hypersensitivity to the study drugs\n* ASA physical status class IV or higher\n* Body mass index (BMI) ≥ 30 kg\u002Fm\\^2\n* Chronic use of opioids or benzodiazepines\n* History of alcohol or drug abuse\n* Preoperative cognitive impairment\n* Severe left ventricular dysfunction (left ventricular ejection fraction \\\u003C 40%)\n* Severe hepatic dysfunction (Child-Pugh class C)\n* Severe hypoalbuminemia (\\\u003C 2.0 g\u002FdL)\n* Acute or chronic renal failure requiring dialysis\n* Pregnancy or breastfeeding\n* Emergency procedure","ALL","20 Years",{"count":137,"type":138},44,"ESTIMATED","INTERVENTIONAL",[141],"PHASE4","The purpose of this study is to compare two intravenous anesthetics, remimazolam and propofol, for their effects on intraoperative hemodynamic stability in patients undergoing thoracic or abdominal endovascular aortic repair. Maintaining blood pressure during these procedures is important to preserve organ perfusion, yet anesthetic-induced hypotension often requires vasopressor support. Since direct comparisons of these two anesthetics on hemodynamic outcomes in this population are limited, this randomized, single-blind, controlled trial will compare the intraoperative vasopressor requirement between the two groups to provide evidence for selecting a more hemodynamically stable anesthetic in these high-risk patients.",[144,145,146,147],"Aortic Aneurysm, Thoracoabdominal","Aortic Aneurysm, Abdominal","Intraoperative Hypotension","Hemodynamic Instability During Anesthesia",[149,150,151,152,153,154,155,156,157],"Remimazolam","Propofol","Total intravenous anesthesia","TEVAR","EVAR","Endovascular aortic repair","Vasoactive-inotropic score","Norepinephrine","Hemodynamic stability","NOT_YET_RECRUITING","2026-09-06",{"date":161,"type":162},"2026-09-10","ACTUAL",{"date":164,"type":138},"2026-09-15",{"date":166,"type":138},"2027-10-30",{"name":5,"class":6},1]