Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hana Pharm Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient-controlled sedation | Experimental | Patient-controlled remimazolam sedation |
|
| Clinician-controlled sedation | Active Comparator | Clinician-controlled remimazolam sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-controlled sedation | Procedure | Patients 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total remimazolam consumption | Weight- and time-adjusted total remimazolam consumption (mg/kg/h) | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score | Range: 20-80 (lower values mean a higher anxious state) | Day before surgery |
| Preoperative mAPAIS | Day before surgery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seokha Yoo, M.D., Ph.D. | Contact | +82-2-2072-2467 | muroki85@snu.ac.kr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinician-controlled sedation | Procedure | Patients 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. |
|
| Baseline quality of recovery (QOR-15-K) score | range:0-150 (a higher value means a better quality of recovery) | Day before surgery |
| Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1 | Range: 20-80 (lower values mean a higher anxious state) | 30 minutes before admission to operation room |
| Intraoperative depth of sedation | Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Frequency of rescue sedative administration | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Incidence of sedation-related adverse events | Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Incidence of respiratory depression | Peripheral oxygen saturation < 95% or apnea > 30 s. | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Frequency of airway interventions | From start to end of anesthesia (the estimated period is up to 6 hours) |
| Length of stay in the post-anesthesia care unit (PACU) | Duration of the post-anesthetic care unit stay | During the day of surgery, an average of 1 hour |
| Patient satisfaction score with sedation | How satisfied the patient was with sedation during surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied) | Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours) |
| Surgeon satisfaction score | How satisfied the surgeon was with the patient sedation during the surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied) | Postoperative period/within 1 hour after surgery |
| Quality of postoperative recovery (QOR-15K) score | range:0-150 (a higher value means a better quality of recovery) | at postoperative 24 hours |