Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Ideal Dosage for Sedation of Obese Patients Undergoing Knee or Hip Arthroplasty Under Spinal Anesthesia - a Phase 4 Clinical Trial

Conditions
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Arthritis Knee, Arthritis Hip

Intervention / Treatment
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* Drug: Remimazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ideal body weight group<br> | Drug: Remimazolam<br>* 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<br>|
| Active Comparator: Total body weight group<br> | Drug: Remimazolam<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative respiratory depression | Incidence of intraoperative respiratory depression | From entrance to exit from the operating room | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |