[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641802":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":39,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":25,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":25},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient-controlled sedation","EXPERIMENTAL","Patient-controlled remimazolam sedation",[13],"Procedure: Patient-controlled sedation",{"label":15,"type":16,"description":17,"interventionNames":18},"Clinician-controlled sedation","ACTIVE_COMPARATOR","Clinician-controlled remimazolam sedation",[19],"Procedure: Clinician-controlled sedation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Patients will receive an initial 0.05 mg\u002Fkg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patients will receive an initial 0.05 mg\u002Fkg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg\u002Fkg\u002Fh. The clinician will assess the MOAA\u002FS score every 10 minutes and adjust the infusion rate to maintain a target MOAA\u002FS score of 3.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Seokha Yoo, M.D., Ph.D.","CONTACT","+82-2-2072-2467","muroki85@snu.ac.kr",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Seokha Yoo","Clinical Associate Professor",[40],{"name":41,"class":42},"Hana Pharm Co., Ltd.","INDUSTRY","100641802","patient-controlled-remimazolam-sedation-under-spinal-anesthesia-100641802",false,"NCT07661810","Patient-controlled Remimazolam Sedation Under Spinal Anesthesia","Patient-controlled Remimazolam Sedation During Primary Hip Arthroplasty Under Spinal Anesthesia: an Open-Label Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 19 to 70 years with an ASA (American Society of Anesthesiologists) physical status of I or II who are undergoing primary hip arthroplasty under spinal anesthesia.\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Patients with contraindications to spinal anesthesia\n* Patients who do not consent to intraoperative sedation\n* Patients with contraindications to remimazolam\n* Patients with a history of allergy or hypersensitivity to remimazolam\n* Patients with a baseline MOAA\u002FS (Modified Observer's Assessment of Alertness\u002FSedation) score of 4 or lower\n* Pregnant women","ALL","19 Years","70 Years",{"count":54,"type":55},104,"ESTIMATED","INTERVENTIONAL",[58],"NA","The goal of this clinical trial is to compare the efficacy of patient-controlled sedation (PCS) versus clinician-controlled sedation (CCS) using remimazolam in adult patients undergoing primary hip arthroplasty under spinal anesthesia.\n\nThe main questions it aims to answer are:\n\n* Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation?\n* Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient\u002Fsurgeon satisfaction?\n\nResearchers will compare the PCS group to the CCS group to see if the patient-controlled method leads to a reduction in total remimazolam consumption while maintaining effective sedation.\n\nParticipants will:\n\n* Be randomly assigned to either the PCS group or the CCS group.\n* In the PCS group: Receive an initial 0.05 mg\u002Fkg remimazolam dose over 1 minute. If deeper sedation is desired, the patient can self-administer a 1 mg bolus of remimazolam via a button press, which has a 1-minute lockout interval.\n* In the CCS group: Receive an initial 0.05 mg\u002Fkg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg\u002Fkg\u002Fh. The clinician will assess the MOAA\u002FS score every 10 minutes and adjust the infusion rate to maintain a target MOAA\u002FS score of 3.",[61,62,63,64],"Hip Arthroplasty","Spinal Anesthesia","Remimazolam","Patient-controlled Sedation",[66,67,68,69],"patient-controlled sedation","remimazolam","spinal anesthesia","hip arthroplasty","NOT_YET_RECRUITING","2026-06-16",{"date":73,"type":74},"2026-06-22","ACTUAL",{"date":76,"type":55},"2026-07-01",{"date":78,"type":55},"2027-05-31",{"name":5,"class":6}]