Hip Arthroplasty, Patient-controlled Sedation, Remimazolam, Spinal Anesthesia
Conditions
Keywords
patient-controlled sedation, remimazolam, spinal anesthesia, hip arthroplasty
Brief summary
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.
Interventions
PROCEDUREPatient-controlled sedation
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.
PROCEDUREClinician-controlled sedation
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.
Sponsors
Seoul National University Hospital
Hana Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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 * Patients with a history of allergy or hypersensitivity to remimazolam * Patients with a baseline MOAA/S (Modified Observer's Assessment of Alertness/Sedation) score of 4 or lower * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total remimazolam consumption | From start to end of anesthesia (the estimated period is up to 6 hours) | Weight- and time-adjusted total remimazolam consumption (mg/kg/h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X2 score | Day before surgery | Range: 20-80 (lower values mean a higher anxious state) |
| Preoperative mAPAIS | Day before surgery | — |
| Baseline quality of recovery (QOR-15-K) score | Day before surgery | range:0-150 (a higher value means a better quality of recovery) |
| Preoperative Korean State-Trait Anxiety Inventory (K-STAI) X1 | 30 minutes before admission to operation room | Range: 20-80 (lower values mean a higher anxious state) |
| Intraoperative depth of sedation | From start to end of anesthesia (the estimated period is up to 6 hours) | Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale |
| 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 | From start to end of anesthesia (the estimated period is up to 6 hours) | Tracking and Reporting Outcomes Of Procedural Sedation (TROOPS) criteria |
| Incidence of respiratory depression | From start to end of anesthesia (the estimated period is up to 6 hours) | Peripheral oxygen saturation \< 95% or apnea \> 30 s. |
| 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) | During the day of surgery, an average of 1 hour | Duration of the post-anesthetic care unit stay |
| Patient satisfaction score with sedation | Postoperative/during the post-anesthetic care unit stay (the estimated period is up to 3 hours) | How satisfied the patient was with sedation during surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied) |
| Surgeon satisfaction score | Postoperative period/within 1 hour after surgery | How satisfied the surgeon was with the patient sedation during the surgery (10-point Likert scale, 10:the most satisfied, 0:the worst satisfied) |
| Quality of postoperative recovery (QOR-15K) score | at postoperative 24 hours | range:0-150 (a higher value means a better quality of recovery) |
Contacts
CONTACTSeokha Yoo, M.D., Ph.D.
Outcome results
None listed