The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adult patients.

Detailed Description
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Sedation during spinal anesthesia can reduce the patient's anxiety and increase satisfaction, but sedatives such as dexmedetomidine and midazolam may cause hemodynamic instability such as hypotension and bradycardia. In previous studies , hypotension occurred in about 33% and bradycardia in about 13% during spinal anesthesia, which is related to reduced cardiac output due to sympathetic blockade and relative activation of the parasympathetic nerve. In the study comparing remimazolam and dexmedetomidine in patients with delirium after orthopedic surgery, the incidence of hypotension was lower in the remimazolam group (10.8%) than in the dexmedetomidine group (39.5%) (p=0.007) and there was no significant difference between the remimazolam group (2.7%) and the dexmedetomidine group (13.2%) in the incidence of bradycardia (p=0.200). However, the effect of remimazolam on the incidence of hypotension during spinal anesthesia has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and dexmedetomidine on the incidence of hypotension during spinal anesthesia in adults patients.

Official Title
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The Effect of Remimazolam and Dexmedetomidine on the Incidence of Hypotension During Spinal Anesthesia

Conditions
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Remimazolam, Spinal Anesthesia

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 surgery under spinal anesthesia, aged 19-79, of ASA class I, II, or III Exclusion Criteria: Patient refusal Contraindications to regional or neuraxial anesthesia (patient refusal, increased intracranial pressure, infection at puncture site, underlying neurologic disease, severe hypovolemia, severe aortic or mitral stenosis, thrombocytopenia or coagulopathy, sepsis) Contraindications or allergy to dexmedetomidine or remimazolam administration Emergency surgery 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam Group<br>sedation with remimazolam | Drug: Remimazolam<br>* 0.075 mg/kg Remimazolam bolus infusion for 1 min, then 0.1 1.0 mg/kg/h continuous infusion<br>* Other names: Byfavo;|
| Active Comparator: Dexmedetomidine group<br>sedation with dexmedetomidine | Drug: Dexmedetomidine<br>* 1 mcg/kg Dexmedetomidine infusion for 10 min, then 0.2 0.7 mcg/kg/h continuous infusion<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypotension | mean blood pressure lower than 65 mmHg or systolic blood pressure lower than 80% of baseline | 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 hypertension | mean blood pressure higher than 120 mmHg or 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 | 
| Intraoperative Ramsay sedation scale | score of 1 6 | Intraoperative period | 
| Number of phenylephrine, ephedrine, atropine administered | number of administration | Intraoperative period |