[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patient-controlled-sedation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patient-controlled-sedation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"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":20,"type":21},104,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30],"Hip Arthroplasty","Spinal Anesthesia","Remimazolam","Patient-controlled Sedation",[32,33,34,35],"patient-controlled sedation","remimazolam","spinal anesthesia","hip arthroplasty","NOT_YET_RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":21},"2026-07-01",{"date":44,"type":21},"2027-05-31",{"name":46,"class":47},"Seoul National University Hospital","OTHER"]