Remimazolam and Propofol Anesthesia in Elderly Patients

July 24, 2023 updated by: Jong Yeop Kim, Ajou University School of Medicine

Comparison of Remimazolam and Propofol Anesthesia on Hemodynamic and Recovery Profile in Elderly Patients

Remimazolam is a recently developed ultra-short agonist acting at the benzodiazepine binding site of the gamma-aminobutyric acid (GABA)A receptor. Remimazolam has a combination of the hemodynamic stability of benzodiazepines and the advantages of propofol, such as rapid onset, short duration of action, and improved controllability.

A recent study showed that the efficacy of two induction doses of remimazolam (6 and 12 mg/kg/h) as a sedative for general anesthesia was not inferior to propofol (2.0-2.5 mg/kg), and hemodynamically more stable. On the other hand, a study on the emergence time and quality between propofol and remimazolam showed inconsistent results.

The purpose of this study is to compare remimazolam to propofol on the intraoperative hemodynamic changes and recovery profiles, when used in combination with remifentanil in elderly patients undergoing general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

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 Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Hospital

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I, II patients over 65 years old undergoing general anesthesia

Exclusion Criteria:

  • cardiac surgery
  • neurosurgery
  • liver surgery
  • uncontrolled hypertension
  • bronchial asthma
  • body mass index ≥ 30 kg/m2
  • severe heart, liver, kidney disease

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam 6
Remimazolam starts at 6 mg/kg/hr until loss of consciousness
Drug: Remimazolam Besylate 6 mg/kg/hr
Patients will receive remimazolam at 6 mg/kg/hr by continuous infusion until loss of consciousness.
Other Names:
  • Byfavo
Experimental: Remimazolam 12
Remimazolam starts at 12 mg/kg/hr until loss of consciousness
Drug: Remimazolam Besylate 12 mg/kg/hr
Patients will receive remimazolam at 12 mg/kg/hr by continuous infusion until loss of consciousness.
Other Names:
  • Byfavo
Active Comparator: Propofol
Propofol starts at a target controlled infusion 4 µg/ml until loss of consciousness.
Drug: Propofol
Patients will receive propofol at a target controlled infusion 4 µg/ml until loss of consciousness.
Other Names:
  • Fresofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
difference in the decreased mean arterial pressure
Time Frame: from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation
difference between baseline mean arterial pressure and lowest mean arterial pressure
from the start of anesthetics (propofol or remimazolam) injection to the 5 minutes after extubation

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

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 (Actual)

February 2, 2022

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

January 18, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 15, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJIRB-MED-INT-21-651

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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