Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation

Study Overview
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Brief Summary
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The purpose of this study is to compare the sedation efficacy of dexmedetomidine and remimazolam for intraoperative sedation during regional block.

Official Title
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Comparison of Remimazolam and Dexmedetomidine for Intraoperative Sedation During Regional Block

Conditions
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Orthopedic Disorder

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for lower extremity surgery under regional anesthesia, aged 19-70, of ASA class I or II. Exclusion Criteria: Patient refusal Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, aortic or mitral stenosis, thrombocytopenia or coagulopathy) Contraindications to dexmedetomidine or remimazolam administration Allergy to dexmedetomidine or remimazolam Baseline MOAA/S score of 4 or less Pregnancy Other conditions considered unsuitable by the investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: Remimazolam<br> | Drug: Remimazolam<br>* 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.5 1.0 mg/kg/h continuous infusion<br>|
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br>* 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2 0.7 mcg/kg/h continuous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rescue sedative doses administered |  | Intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative bradycardia (heart rate lower than 45 bpm) |  | Intraoperative period | 
| Incidence of intraoperative hypotension (mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline) |  | Intraoperative period | 
| Incidence of intraoperative hypertension (systolic blood pressure higher than 120% of baseline) |  | Intraoperative period | 
| Incidence of respiratory depression (respiratory rate lower than 8 per minute) |  | Intraoperative period | 
| Incidence of hypoxia (oxygen saturation detected by pulse oxymetry less than 93%) |  | Intraoperative period | 
| MOAA/S score (Modified Observer's Assessment of Alertness and Sedation, 0=unarousable, 5=alert) |  | Intraoperative period | 
| Intraoperative PSi (Patient State index) |  | Intraoperative period | 
| Electroencephalogram data (alpha, beta, delta, theta waves) |  | Intraoperative period | 
| Time to reach MOAA/S = 5 after end of drug infusion |  | Intraoperative period and post-anesthesia care period (immediate post-operative period) | 
| Oxygen supply at the post-anesthesia care unit |  | Post-anesthesia care period (immediate post-operative period) | 
| Incidence of postoperative delirium |  | Immediately after the surgery, up to 5 days after surgery | 
| Incidence of nausea/vomiting |  | Intraoperative period and post-anesthesia care period (immediate post-operative period) | 
| Postoperative spinal anesthesia block level |  | Postoperative period, up to 12h hours after end of surgery | 
| Duration of stay in the post-anesthsia care unit(PACU) |  | Immediate postoperative period | 
| Patient satisfaction (numerical rating scale of 0 10) | 0 Not at all satisfied, 10 very satisfied | Immediately after the surgery, up to 5 days after surgery | 
| Serum CRP level |  | Preoperative baseline and second postoperative day |