About this trial
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.
The main questions it aims to answer are:
* Does patient-controlled sedation significantly reduce the total consumption of remimazolam compared to clinician-controlled sedation? * Are there differences in secondary outcomes, such as sedation depth , sedation-related adverse events, frequency of airway interventions, and patient/surgeon satisfaction?
Researchers 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.
Participants will:
* Be randomly assigned to either the PCS group or the CCS group. * In the PCS group: Receive an initial 0.05 mg/kg 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. * In the CCS group: Receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Refusal to participate in the study
Patients with contraindications to spinal anesthesia
Patients who do not consent to intraoperative sedation
Patients with contraindications to remimazolam
Trial design
Parallel
Treatments tested in this trial
Patient-controlled sedation
Procedure/SurgeryPatients will receive an initial 0.05 mg/kg 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.
Clinician-controlled sedation
Procedure/SurgeryPatients will receive an initial 0.05 mg/kg remimazolam dose over 1 minute, followed by a continuous infusion starting at 0.3 mg/kg/h. The clinician will assess the MOAA/S score every 10 minutes and adjust the infusion rate to maintain a target MOAA/S score of 3.
Treatment groups
Trial outcomes
Primary outcomes
Total remimazolam consumption
Weight- and time-adjusted total remimazolam consumption (mg/kg/h)
Secondary outcomes
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score
Range: 20-80 (lower values mean a higher anxious state)
Preoperative mAPAIS
Baseline quality of recovery (QOR-15-K) score
range:0-150 (a higher value means a better quality of recovery)
Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1
Range: 20-80 (lower values mean a higher anxious state)
Locations
Sponsors and contacts
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Seoul National University Hospital
Lead sponsor
Hana Pharm Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: