[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":26,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":26,"enrollmentInfo":47,"targetDuration":26,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":26,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":26},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam","EXPERIMENTAL","Participants receive general anesthesia induced and maintained with remimazolam-based total intravenous anesthesia. At the end of surgery, flumazenil (0.2-1.0 mg) is administered to reverse the sedative effect.",[13],"Drug: Remimazolam with Flumazenil",{"label":15,"type":16,"description":17,"interventionNames":18},"Propofol","ACTIVE_COMPARATOR","Participants receive general anesthesia induced and maintained with propofol.",[19],"Drug: Propofol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Remimazolam with Flumazenil","General anesthesia is induced and maintained with remimazolam (initial infusion approximately 6 mg\u002Fkg\u002Fhr for induction, then 1-2 mg\u002Fkg\u002Fhr for maintenance), along with remifentanil for analgesia. At the end of surgery, flumazenil is administered to reverse the sedative effect, starting with 0.2 mg IV, followed by 0.1 mg incremental doses every 1 minute as needed, up to a total dose of 1.0 mg.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"General anesthesia is induced and maintained with propofol using target-controlled infusion (effect-site concentration up to 4.0 μg\u002FmL), along with remifentanil for analgesia.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Kyung Won Shin","CONTACT","02-2072-2469","skwskw126@gmail.com",{"type":37,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100613320","comparison-of-emergence-agitation-between-remimazolam-with-flumazenil-and-propofol-based-total-intravenous-anesthesia-in-patients-undergoing-nasal-surgery-100613320",false,"NCT07265050","Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery","Comparison of Emergence Agitation Between Remimazolam With Flumazenil and Propofol-based Total Intravenous Anesthesia in Patients Undergoing Nasal Surgery: A Randomized Controlled Trial","Inclusion Criteria\n\n\\- Adults aged 19 years or older scheduled to undergo nasal surgery requiring general anesthesia\n\nExclusion Criteria\n\n* Declines or is unable to provide informed consent\n* Body mass index (BMI) ≥ 30 kg\u002Fm²\n* Pre-existing neurological or cognitive impairment\n* Known contraindication or allergy to remimazolam, propofol, or flumazenil\n* Any condition judged by the investigator to make participation inappropriate (e.g., unstable medical status, severe comorbidities)","ALL","19 Years",{"count":48,"type":49},204,"ESTIMATED","INTERVENTIONAL",[52],"NA","Participants will be randomly assigned to receive general anesthesia with either remimazolaml-based total intravenous anesthesia reversed with flumazenil or propofol-based total intravenous anesthesia. The primary outcome is the incidence of emergence agitation evaluated at the time of awakening after surgery. Additional outcomes include time to extubation, hemodynamic stability, airway complications such as coughing or laryngospasm, and postoperative recovery profiles including pain, nausea, vomiting, and sedation in the post-anesthesia care unit. This study aims to determine whether remimazolam with flumazenil provides smoother emergence compared with propofol in patients undergoing nasal surgery.",[55],"Emergence Agitation","NOT_YET_RECRUITING","2025-11-23",{"date":59,"type":60},"2025-12-04","ACTUAL",{"date":62,"type":49},"2026-01-01",{"date":64,"type":49},"2027-12-31",{"name":5,"class":6}]