Bolus Versus Continuous Remimazolam for Anesthetic Induction

Study Overview
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Brief Summary
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Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion. This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.

Official Title
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Comparison of the Incidence of Hypotension in Bolus Versus Continuous Administration of Remimazolam During Anesthesia Induction

Conditions
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Hypotension on Induction

Intervention / Treatment
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* Drug: Remimazolam bolus
* Drug: Remimazolam continuous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scheduled for elective surgery under general anesthesia adult patient (over 19 years old) American Society of Anesthesiology Physical Status I-III Exclusion Criteria: arrythmia liver dysfunction kidney dysfunction uncontrolled hypertension uncontrolled diabetes mellitus allergic to benzodiazepines heart failure drug intoxication alcohol intoxication

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus<br>Anesthetic induction with bolus remimazolam administration | Drug: Remimazolam bolus<br>* Remimazolam bolus 0.14-0.33 mg/kg 0.25-0.33 mg/kg, <40 years 0.19-0.25 mg/kg, 60-80 years 0.14-0.19 mg/kg, >80 years<br>|
| Experimental: Continuous<br>Anesthetic induction with continuous remimazolam administration | Drug: Remimazolam continuous<br>* Remimazolam 12 mg/kg/hr<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | Systolic pressure below 90 mmHg | 10 minutes after anesthetic induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bradycardia | heart rate below 40 beats per minute | 10 minutes after anesthetic induction | 
| The lowest systolic blood pressure | The lowest systolic blood pressure | 10 minutes after anesthetic induction | 
| Number of participants with vasoactive drug use | Use of vasoactive drug for the blood pressure or the heart rate management | 10 minutes after anesthetic induction | 
| Time to loss of consciousness | Time from drug administration to loss of consciousness | 10 minutes after anesthetic induction | 
| Dosage of remimazolam | Total dose or remimazolam used for anesthetic induction | 10 minutes after anesthetic induction |