Bolus Versus Continuous Remimazolam for Anesthetic Induction

May 31, 2023 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bolus
Anesthetic induction with bolus remimazolam administration
Drug: Remimazolam bolus
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
Experimental: Continuous
Anesthetic induction with continuous remimazolam administration
Drug: Remimazolam continuous
Remimazolam 12 mg/kg/hr

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Investigators

  • Principal Investigator: Cho E Ah, Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMZ_bolcon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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