Bolus Versus Continuous Remimazolam for Anesthetic Induction

Not Applicable

Not yet recruiting

• Conditions: Hypotension on Induction
• Interventions: Drug: Remimazolam bolus; Drug: Remimazolam continuous

• Registration Number: NCT05536323
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-05
• Study First Submitted QC: 2022-09-07
• Study First Posted: 2022-09-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-31
• Last Update Posted: 2023-06-02
• Study Start: 2023-07-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus	Remimazolam bolus	Anesthetic induction with bolus remimazolam administration
Continuous	Remimazolam continuous	Anesthetic induction with continuous remimazolam administration

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	10 minutes after anesthetic induction	Systolic pressure below 90 mmHg

Secondary Outcome Measures

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