Hypotension After Anesthetic Induction With Remimazolam in Elderly

Study Overview
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Brief Summary
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Even though remimazolam is known to be safely administered without hemodynamic instability, hypotension is the one of the common side effects of remimazolam. Because elderly patients are susceptible to hypotension due to old age, multimodality, and multiple medications, hypotension can be harmful in elderly patients. Remimazolam can be administered either bolus or continuous for anesthetic induction. In our study the investigators aimed to compare the incidence of hypotension after anesthetic induction using remimazolam by bolus injection and continuous infusion in elderly patients.

Official Title
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Comparison of the Incidence of Hypotension With Bolus Versus Continuous Remimazolam for Anesthetic Induction in Elderly Patients

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Bolus of remimazolam
* Drug: Continuous infusion of remimazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients with age over 60 years old scheduled for elective surgery under general anesthesia American Society of Anesthesiology Physical Status I-III Exclusion Criteria: Arrhythmia Liver dysfunction Kidney dysfunction Uncontrolled hypertension Uncontrolled diabetes mellitus Allergic to benzodiazepines Heart failure Drug intoxication Alcoholics Cognitive dysfunction Unable to understand and consent voluntarily

Ages Eligible for Study
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Minimum Age: 60 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>Remimazolam bolus injection for 20 seconds | Drug: Bolus of remimazolam<br>* 0.19-0.25 mg/kg for 60-80 years old 0.14-0.19 mg/kg for >80 years old<br>|
| Active Comparator: Continuous<br>Remimazolam continuous infusion | Drug: Continuous infusion of remimazolam<br>* 12 mg/kg/hr until loss of consciousness<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hypotension | Systolic blood pressure < 90 mmHg | 10 minutes after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of bradycardia | Heart rate < 40 beats per minute | 10 minutes after intubation | 
| Number of participants with use of any vasopressors | Use of ephedrine, phenylephrine | 10 minutes after intubation | 
| Lowest systolic blood pressure | The lowest systolic blood pressure measured within10 minutes after intubation | 10 minutes after intubation | 
| Time to loss of consciousness | Time to loss of consciousness. Loss of consciousness is assessed by the loss of response to shoulder shaking. | 10 minutes after intubation | 
| Total remimazolam used for anesthetic induction | Sum of remimazolam used during anesthetic induction | 10 minutes after intubation |