Arthritis Hip, Arthritis Knee
Conditions
Brief summary
This study aims to compare ideal body weight- and total body weight-based dosage for remimazolam sedation of obese patients undergoing knee or hip arthroplasty under spinal anesthesia.
Interventions
DRUGRemimazolam
0.075 mg/kg Remimazolam will be loaded over 1 min, then continuously infused at 0.2-1.0 mg/kg/h based on ideal or total body weight
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for elective knee or hip arthroplasty under spinal anesthesia * BMI\>25 * American Society of Anesthesiologists (ASA) classification I, II, III
Exclusion criteria
* Patient refusal * Contraindication for spinal anesthesia * Contraindication for remimazolam infusion * History of hypersensitivity to remimazolam * History of chronic use of benzodiazepine or opioid * Baseline MOAA/S score of 4 or lower * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative respiratory depression | From entrance to exit from the operating room | Incidence of intraoperative respiratory depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative hypotension | From entrance to exit from the operating room | Mean blood pressure \<65 mmHg |
| Incidence of intraoperative hypertension | From entrance to exit from the operating room | Systolic blood pressure \>120% of baseline |
| Incidence of intraoperative bradycardia | From entrance to exit from the operating room | Heart rate \<45 bpm |
| Incidence of intraoperative tachycardia | From entrance to exit from the operating room | Heart rate \>120 bpm |
| Incidence of intraoperative oxygen desaturation | From entrance to exit from the operating room | Pulse oximeter saturation (SpO2) \< 93% |
| Incidence of intraoperative nausea or vomiting | From entrance to exit from the operating room | Nausea or vomiting during surgery |
| Incidence of intraoperative hiccups | From entrance to exit from the operating room | Hiccups during surgery |
| Incidence of intraoperative paradoxical movements | From entrance to exit from the operating room | Paradoxical movements during surgery |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score | From start of remimazolam infusion until time of full alertness | MOAA/S score assessment at 10 min intervals |
| Total remimazolam infusion dose | From start to end of remimazolam infusion | Total remimazolam infusion dose (mg/kg/h) |
| Time to reach MOAA/S score 5 after end of surgery | From end of remimazolam infusion until time of full alertness | Time to reach MOAA/S score 5 (min) |
| Length of stay at the post-anesthesia care unit (PACU) | From entrance to exit from the PACU | Length of stay at the PACU (min) |
| Patient satisfaction | At exit from PACU | Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied) |
| Intraoperative recall | At exit from PACU | Assessment with the modified Brice questionnaire |
| Incidence of postoperative nausea or vomiting | From entrance to exit from the PACU | Incidence of nausea or vomiting |
| Incidence of postoperative delirium | From end of surgery to third postoperative day | Assessment with the Confusion Assessment Method (CAM) |
| Incidence of postoperative respiratory depression | From entrance to exit from the PACU | Respiratory rate \< 8/min or SpO2\<93% |
| Incidence of postoperative hypotension | From entrance to exit from the PACU | Mean blood pressure \<65 mmHg |
| Incidence of postoperative hypertension | From entrance to exit from the PACU | Systolic blood pressure \>120% from baseline |
| Intraoperative Patient State Index (PSi) | From entrance to exit from the operating room | Continuous monitoring of PSi with Sedline sensor |
Countries
South Korea
Outcome results
None listed