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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ideal body weight group | Experimental |
| |
| Total body weight group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative respiratory depression | Incidence of intraoperative respiratory depression | From entrance to exit from the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| Total remimazolam infusion dose | Total remimazolam infusion dose (mg/kg/h) | From start to end of remimazolam infusion |
| Incidence of intraoperative hypotension | Mean blood pressure <65 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin-Tae Kim | Seoul | South Korea |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
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| From entrance to exit from the operating room |
| Incidence of intraoperative hypertension | Systolic blood pressure >120% of baseline | From entrance to exit from the operating room |
| Incidence of intraoperative bradycardia | Heart rate <45 bpm | From entrance to exit from the operating room |
| Incidence of intraoperative tachycardia | Heart rate >120 bpm | From entrance to exit from the operating room |
| Incidence of intraoperative oxygen desaturation | Pulse oximeter saturation (SpO2) < 93% | From entrance to exit from the operating room |
| Incidence of intraoperative nausea or vomiting | Nausea or vomiting during surgery | From entrance to exit from the operating room |
| Incidence of intraoperative hiccups | Hiccups during surgery | From entrance to exit from the operating room |
| Incidence of intraoperative paradoxical movements | Paradoxical movements during surgery | From entrance to exit from the operating room |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score | MOAA/S score assessment at 10 min intervals | From start of remimazolam infusion until time of full alertness |
| Intraoperative Patient State Index (PSi) | Continuous monitoring of PSi with Sedline sensor | From entrance to exit from the operating room |
| Time to reach MOAA/S score 5 after end of surgery | Time to reach MOAA/S score 5 (min) | From end of remimazolam infusion until time of full alertness |
| Length of stay at the post-anesthesia care unit (PACU) | Length of stay at the PACU (min) | From entrance to exit from the PACU |
| Patient satisfaction | Numeric rating scale of 0 (not satisfied at all) to 10 (absolutely satisfied) | At exit from PACU |
| Intraoperative recall | Assessment with the modified Brice questionnaire | At exit from PACU |
| Incidence of postoperative nausea or vomiting | Incidence of nausea or vomiting | From entrance to exit from the PACU |
| Incidence of postoperative delirium | Assessment with the Confusion Assessment Method (CAM) | From end of surgery to third postoperative day |
| Incidence of postoperative respiratory depression | Respiratory rate < 8/min or SpO2<93% | From entrance to exit from the PACU |
| Incidence of postoperative hypotension | Mean blood pressure <65 mmHg | From entrance to exit from the PACU |
| Incidence of postoperative hypertension | Systolic blood pressure >120% from baseline | From entrance to exit from the PACU |