Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in OPCAB Patients

November 20, 2023 updated by: Yunseok Jeon, Seoul National University Hospital

Effect of Remimazolam and Propofol on Hemodynamic Stability During Anesthesia Induction in Patients Undergoing Coronary Artery Bypass Grafting

Remimazolam is a novel ultra-short-acting benzodiazepine. Several studies demonstrated that its efficacy as a sedative hypnotics for general anesthesia is non-inferior to propofol. However, evidence on the hemodynamic stability of remimazolam for the anesthesia induction in patients undergoing coronary artery bypass grafting is lacking. This prospective randomized trial aims to compare hemodynamic stability during anesthesia induction between remimazolam and propofol in patients undergoing coronary artery bypass grafting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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

Study Locations

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patient (aged 19 years or older) who scheduled for elective coronary artery bypass grafting

Exclusion Criteria:

  • Patients who refuse to participate
  • Concomitant heart valve surgery or thoracic aorta surgery
  • Emergent surgery
  • Preoperative sedation
  • Intubated state
  • Patients with mechanical circulatory assist device
  • Preoperative use of inotropes or vasopressors
  • History of allergy or adverse reaction to study drugs
  • Rapid sequence intubation
  • Lactose intolerance
  • Peanut allergy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
Drug: Rocuronium
After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed
Drug: Sufentanil
During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.
Drug: Propofol
For the induction of anesthesia, patients allocated to the propofol group will receive a bolus dose of propofol 1.5 mg/kg. After the loss of consciousness, general anesthesia will be maintained with sevoflurane to achieve a bispectral index of 40 to 60.
Experimental: Remimazolam
Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]
For the induction of anesthesia, patients allocated to the remimazolam group will receive intravenous infusion of remimazolam at a rate of 6 mg/kg/h, followed by 1 mg/kg/h after the loss of consciousness. The infusion rate of remimazolam will be adjusted to a maximum rate of 2 mg/kg/h to achieve a bispectral index of 40 to 60.
Other Names:
  • Remimazolam Besylate
Drug: Rocuronium
After the loss of consciousness, a bolus of rocuronium 1 mg/kg was intravenously administered. After 90 seconds of manual ventilation, endotracheal intubation was performed
Drug: Sufentanil
During the study period, a total dose of sufentanil 0.5-2.0 mcg/kg was intravenously administered at the attending anesthesiologists' discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MAP-time integral
Time Frame: During 10 minute from the administration of the study drug
The area under the baseline MAP (sec * mmHg). Baseline MAP was defined as the mean MAP over the 3 min period immediately before induction.
During 10 minute from the administration of the study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to loss of consciousness
Time Frame: During 10 minute from the administration of the study drug
The time from the study drug administration to loss of consciousness
During 10 minute from the administration of the study drug
Mean blood pressure
Time Frame: During 10 minute from the administration of the study drug
maximum / minimum value (mmHg)
During 10 minute from the administration of the study drug
Heart rate
Time Frame: During 10 minute from the administration of remimazolam or propofol
maximum / minimum / mean / median / time-weighted average values (bpm)
During 10 minute from the administration of remimazolam or propofol
Regional cerebral oxygen saturation
Time Frame: During 10 minute from the administration of the study drug
continuous monitoring of regional cerebral oxygen saturation during surgery (%)
During 10 minute from the administration of the study drug
Cardiac output
Time Frame: During 10 minute from the administration of the study drug
continuous monitoring of cardiac output (L/min)
During 10 minute from the administration of the study drug
Sufentanil dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered sufentanil (mcg)
During 10 minute from the administration of the study drug
Crystalloid
Time Frame: During 10 minute from the administration of the study drug
Total volume of administered crystalloid (ml)
During 10 minute from the administration of the study drug
Study drug dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered remimazolam or propofol (mg)
During 10 minute from the administration of the study drug
Number of vasopressor administration
Time Frame: During 10 minute from the administration of the study drug
  1. Total number (n)
  2. Ephedrine (n)
  3. Phenylephrine (n)
  4. Vasopressin (n)
  5. Norepinephrine (n)
During 10 minute from the administration of the study drug
Ephedrine dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered ephedrine (mg)
During 10 minute from the administration of the study drug
Phenylephrine dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered phenylephrine (mcg)
During 10 minute from the administration of the study drug
Vasopressin dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered vasopressin (unit) 2. Ephedrine: total dose / number of administration 3. Phenylephrine: total dose / number of administration 4. Vasopressin: total dose / number of administration 5. Norepinephrine: total dose / number of administration
During 10 minute from the administration of the study drug
Norepinephrine dose
Time Frame: During 10 minute from the administration of the study drug
Total dose of administered norepinephrine (mcg)
During 10 minute from the administration of the study drug

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Yunseok Jeon, MD, PhD, Seoul National University 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 (Actual)

July 26, 2022

Primary Completion (Actual)

November 8, 2023

Study Completion (Actual)

November 8, 2023

Study Registration Dates

First Submitted

June 12, 2022

First Submitted That Met QC Criteria

June 14, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Remimazolam_OPCAB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Hemodynamic Instability

Clinical Trials on REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe