[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644453":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":72,"collaborators":28,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":28,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":28,"enrollmentInfo":83,"targetDuration":28,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":104,"whyStopped":28,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Chung-Ang University Gwangmyeong Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"remimazolam-fumazeil group","EXPERIMENTAL","Participants will receive remimazolam for induction and maintenance of general anesthesia. At the end of surgery, flumazenil will be administered to facilitate rapid emergence from anesthesia. Standardized perioperative management, including fentanyl, rocuronium, supraglottic airway management, and postoperative monitoring, will be applied.",[13,14],"Drug: Remimazolam","Drug: Flumazenil",{"label":16,"type":17,"description":18,"interventionNames":19},"sevoflurane group","ACTIVE_COMPARATOR","Participants will receive propofol for induction of general anesthesia followed by maintenance with sevoflurane-based balanced anesthesia. Standardized perioperative management will be applied similarly to the experimental group.",[20,21],"Drug: Sevoflurane","Drug: propofol",[23,29,33,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Remimazolam","Remimazolam will be administered at 12 mg\u002Fkg\u002Fh for induction of anesthesia until loss of consciousness, followed by maintenance at 1-2 mg\u002Fkg\u002Fh until the end of surgery.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Flumazenil","Flumazenil 0.5 mg will be administered intravenously at the end of surgery to reverse remimazolam-induced sedation. Additional doses of 0.2 mg may be administered if necessary, up to a maximum total dose of 1.0 mg.",[9],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Sevoflurane","Sevoflurane will be administered at 1.5-3.5 vol% for maintenance of anesthesia following propofol induction. At the end of surgery, sevoflurane administration will be discontinued and washout will be facilitated using fresh gas flow of 6 L\u002Fmin.",[16],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"propofol","Propofol 2 mg\u002Fkg will be administered intravenously for induction of anesthesia before initiation of sevoflurane maintenance.",[16],[42],{"name":43,"affiliation":5,"role":44},"Jiwon Han","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Jiwon Han, MD, PhD","CONTACT","+82-10-3447-1988","yesuroon@gmail.com",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},"Haesun Jung, MD","82-10-9452-0448","sunnyj0107@gmail.com",[56],{"facility":5,"status":28,"city":57,"state":58,"zip":59,"country":60,"countryCode":28,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Gwangmyeong","Gyeonggi-do","14353","South Korea",{"type":62,"coordinates":63},"Point",[64,65],126.86639,37.47722,{"lat":65,"lon":64},[68,70,71],{"name":47,"role":48,"phone":69,"phoneExt":28,"email":50},"82-10-3447-1988",{"name":52,"role":48,"phone":53,"phoneExt":28,"email":54},{"name":47,"role":44,"phone":28,"phoneExt":28,"email":28},{"type":44,"investigatorFullName":43,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Assistant Professor, Department of Anesthesiology and Pain Medicine, Chung-Ang University Gwangmyeong Hospital","100644453","phase-4-remimazolam-flumazenil-versus-sevoflurane-for-hysteroscopic-day-surgery-100644453",false,"NCT07663877","Remimazolam-Flumazenil Versus Sevoflurane for Hysteroscopic Day Surgery","Remimazolam With Planned Flumazenil Reversal Versus Sevoflurane-based Balanced Anesthesia for Hysteroscopic Day Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Female patients aged 20 years or older.\n* Scheduled to undergo ambulatory hysteroscopic surgery under general anesthesia.\n* Able to provide written informed consent.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n\nExclusion Criteria:\n\n* Known hypersensitivity to benzodiazepines, remimazolam, or flumazenil.\n* Chronic use of benzodiazepines or opioids.\n* Severe hepatic dysfunction (Child-Pugh class B or C).\n* Severe renal dysfunction (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n* Epilepsy or other significant neurologic disorders.\n* Pregnancy or breastfeeding.\n* Body mass index (BMI) ≥35 kg\u002Fm².\n* Severe obstructive sleep apnea.\n* Uncontrolled serious systemic disease that may preclude ambulatory surgery.\n* Refusal or inability to provide informed consent.","FEMALE","20 Years",{"count":84,"type":85},124,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","This prospective, single-center, randomized controlled trial aims to compare remimazolam anesthesia with planned flumazenil reversal and sevoflurane-based balanced anesthesia in adult women undergoing ambulatory hysteroscopic surgery.\n\nParticipants will be randomly assigned in a 1:1 ratio to receive either remimazolam for induction and maintenance followed by flumazenil reversal or propofol induction followed by sevoflurane-based balanced anesthesia. The primary outcome is anesthesia-controlled time, defined as the sum of induction time and emergence time. Secondary outcomes include recovery profiles, postoperative symptoms, quality of recovery, hemodynamic stability, and the incidence of re-sedation. The study will evaluate whether a remimazolam-flumazenil strategy can improve operating room efficiency while maintaining recovery quality and safety comparable to conventional sevoflurane-based anesthesia in the ambulatory surgery setting.",[91,92,93],"Hysteroscopy","Ambulatory Surgery","General Anesthesia",[95,96,97,98,99,100,101,102,103],"remimazolam","flumazenil","sevoflurane","ambulatory surgery","day surgery","hysteroscopy","general anesthesia","recovery profile","anesthesia controlled time","NOT_YET_RECRUITING","2026-06-17",{"date":107,"type":108},"2026-06-23","ACTUAL",{"date":110,"type":85},"2026-06",{"date":112,"type":85},"2028-06",{"name":5,"class":6},1]