[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655713":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":42,"studyPopulation":42,"armGroups":49,"interventions":61,"overallOfficials":42,"centralContacts":71,"locations":77,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":42,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":42,"enrollmentInfo":109,"targetDuration":42,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":123,"overallStatus":130,"whyStopped":42,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of postoperative cognitive decline","Postoperative cognitive function will be assessed using the Korean Mini-Mental State Examination (K-MMSE) and the Korean version of the Montreal Cognitive Assessment (MoCA-K). Both assessments will be performed preoperatively and again on postoperative day 7 or before hospital discharge. Postoperative cognitive dysfunction will be defined as a decrease of ≥2 points from the preoperative baseline score in either the K-MMSE or MoCA-K.","Preoperative baseline to postoperative day 7 or before hospital discharge",[14,18,21,25,28,32],{"measure":15,"description":16,"timeFrame":17},"Change in plasma IL-1β concentration","Plasma interleukin-1 beta (IL-1β) concentration will be measured at preoperative baseline and 2-4 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-1β concentration will be measured in pg\u002FmL using the Meso Scale Discovery assay.","Preoperative baseline to 2-4 hours after completion of cardiopulmonary bypass",{"measure":19,"description":20,"timeFrame":17},"Change in plasma TNF-α concentration","Plasma tumor necrosis factor-alpha (TNF-α) concentration will be measured at preoperative baseline and 2-4 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma TNF-α concentration will be measured in pg\u002FmL using the Meso Scale Discovery assay.",{"measure":22,"description":23,"timeFrame":24},"Change in plasma IL-6 concentration","Plasma interleukin-6 (IL-6) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-6 concentration will be measured in pg\u002FmL using the Meso Scale Discovery assay.","Preoperative baseline to 24 hours after completion of cardiopulmonary bypass",{"measure":26,"description":27,"timeFrame":24},"Change in plasma IL-10 concentration","Plasma interleukin-10 (IL-10) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. Plasma IL-10 concentration will be measured in pg\u002FmL using the Meso Scale Discovery assay.",{"measure":29,"description":30,"timeFrame":31},"Change in plasma HMGB1 concentration","Plasma high mobility group box 1 (HMGB1) concentration will be measured at preoperative baseline, 2-4 hours after completion of cardiopulmonary bypass, and 24 hours after completion of cardiopulmonary bypass. Changes from baseline will be compared between the remimazolam and propofol groups. Plasma HMGB1 concentration will be measured in pg\u002FmL using the Multiplex bead assay.","Preoperative baseline through 24 hours after completion of cardiopulmonary bypass",{"measure":33,"description":34,"timeFrame":24},"Change in plasma GFAP concentration","Plasma glial fibrillary acidic protein (GFAP) concentration will be measured at preoperative baseline and 24 hours after completion of cardiopulmonary bypass. The change from baseline will be compared between the remimazolam and propofol groups. GFAP will be analyzed using the Single Molecule Array (Simoa) assay.",[36],{"measure":37,"description":38,"timeFrame":12},"Incidence of postoperative delirium","Postoperative delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). The incidence of postoperative delirium will be compared between the remimazolam and propofol groups.",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":45,"maskingDescription":42,"whoMasked":46},"DOUBLE",[47,48],"PARTICIPANT","OUTCOMES_ASSESSOR",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Remimazolam group","EXPERIMENTAL","Remimazolam Besylate (2mg\u002FmL)",[55],"Drug: Remimazolam Besylate",{"label":57,"type":52,"description":58,"interventionNames":59},"Propofol group","Propofol (20mg\u002FmL)",[60],"Drug: propofol",[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":42},"DRUG","Remimazolam Besylate","\\- Continuous drug: remimazolam diluted to 2 mg\u002FmL in normal saline - Maintenance: 1-2 mg\u002Fkg\u002Fh (titrated to BIS 40-60, max 2 mg\u002Fkg\u002Fh)",[51],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":42},"propofol","Continuous drug: propofol (undiluted, 20 mg\u002FmL) - Administration: target-controlled infusion (TCI, Marsh model) - Maintenance: 1-1.5 μg\u002FmL (titrated to BIS 40-60)",[57],[72],{"name":73,"role":74,"phone":75,"phoneExt":42,"email":76},"Youn Joung Cho, M.D., Ph.D.","CONTACT","82-2-2072-2467","mingming7@gmail.com",[78],{"facility":5,"status":42,"city":79,"state":42,"zip":80,"country":81,"countryCode":42,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Seoul","03080","South Korea",{"type":83,"coordinates":84},"Point",[85,86],126.9784,37.566,{"lat":86,"lon":85},[89],{"name":90,"role":74,"phone":91,"phoneExt":42,"email":76},"Youn Joung Cho, MD. PhD.","82-2-2072-3108",{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Youn Joung Cho, MD, PhD","Clinical Associate Professor",[97],{"name":98,"class":99},"Hana Pharm Co., Ltd.","INDUSTRY","100655713","phase-4-effects-of-remimazolam-on-postoperative-cognitive-dysfunction-and-neuroinflammatory-biomarkers-in-patients-undergoing-aortic-arch-surgery-100655713",false,"NCT07816068","Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery","Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Patients scheduled to undergo total or partial aortic arch replacement for aortic arch disease, with planned circulatory arrest and\u002For selective cerebral perfusion as a cerebral protection strategy during surgery\n\nExclusion Criteria:\n\n* Pre-existing cognitive impairment, defined as Mini-Mental State Examination (MMSE) score \\\u003C24\n* Acute cerebral hemorrhage or cerebral infarction within the previous 3 months\n* History of hypersensitivity to remimazolam or other benzodiazepines\n* History of alcohol or substance abuse\n* Chronic use of opioids or benzodiazepines\n* Severe hepatic impairment (Child-Pugh class C)\n* Acute or chronic renal failure requiring dialysis Emergency surgery or acute aortic dissection","ALL","19 Years",{"count":110,"type":111},80,"ESTIMATED","INTERVENTIONAL",[114],"PHASE4","The purpose of this study is to compare remimazolam- and propofol-based anesthesia for their effects on postoperative cognitive dysfunction in patients undergoing aortic arch surgery. These procedures involve a substantial risk of cerebral ischemia and reperfusion injury, which may contribute to postoperative cognitive decline. Although experimental studies have suggested potential neuroprotective effects of remimazolam, clinical evidence in patients undergoing high-risk aortic arch surgery remains limited. This prospective, randomized controlled trial will compare the incidence of postoperative cognitive dysfunction between patients receiving remimazolam- or propofol-based anesthesia. In addition, changes in circulating neuroinflammatory and neuronal injury biomarkers will be evaluated to explore the potential mechanisms underlying any neuroprotective effect of remimazolam. The findings may provide clinical evidence to guide anesthetic selection and improve neurological outcomes in patients undergoing aortic arch surgery.",[117,118,119,120,121,122],"Aortic Aneurysm of the Proximal Arch","Aortic Aneurysms Arch","Aortic Arch Disease","Postoperative Delirium (POD)","POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE","Postoperative Delirium",[124,125,126,127,128,129],"Remimazolam","Propofol","Arch surgery","Arch disease","postoperative delirium","POCD (postoperative clinical decline)","NOT_YET_RECRUITING","2026-09-14",{"date":133,"type":134},"2026-09-17","ACTUAL",{"date":136,"type":111},"2026-10-01",{"date":138,"type":111},"2027-11-30",{"name":5,"class":6},1]