Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery

The Impact of Remimazolam and Propofol on the Left Ventricular Systolic Performance During Anesthesia-induction for Non-cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery.

LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.

Study Overview

• Status: Recruiting
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Drug: Remimazolam infusion; Drug: Propofol infusion

Detailed Description

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery (n=40).

Remimazolam or propofol is randomly administered for anesthesia induction (Group-R and Group-P, respectively) The changes of LV-GLS are analyzed by using using speckle tracking technique. For this study, 2-dimensional of transthoracic echocardiography LV images (apical 2-chamber, 3-chamber, and 4-chamber views) are recorded and stored before administration of remimazolam/propofol (T0), 2 minutes after the administration (T2), 4 minutes after the administration (T4), and 6 minutes after the administration (T6).

After the completion of the study, LV-GLS values at T0, T2, T4 and T6 are determined by the off-line analyses of the recorded and stored 2D-images.

For the off-line determination of LV-GLS, an automated software of speckle-tracking technique (Qapp Autostrain-LV™, Philips) is employed.

The primary measure:

Inter-group comparison of the lowest LV-GLS value out of LV-GLS values at T2, T4, and T6.

The secondary measures:

Inter-group comparisons of the LV-GLS values at T0, T2, T4 and T8. Intra-group comparisons of the LV-GLS value at T0 vs. those at T2, T4 and T8

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tae-Yop Kim, MD, PhD; Phone Number: +82-10-8811-6942; Email: taeyop@gmail.com
• Study Contact Backup: Name: Soi Lee; Email: soileekku@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05030
    • Recruiting
    • Konkuk University Medical Center
    • Contact: Seong-Ho Lee; Phone Number: +82-2-2030-6542; Email: irb@kuh.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• left ventricular ejection fraction> 50%
• no left ventricular regional wall motion abnormality

Exclusion Criteria:

• atrial fibrillation
• unfavorable airway
• hypotension requiring inotropic support

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam; remimazolam infusion	Drug: Remimazolam infusion; Remimazolam infusion for anesthesia induction; Other Names: Byfavo
Active Comparator: Propofol; propofol infusion	Drug: Propofol infusion; Propofol infusion for anesthesia induction; Other Names: Fresofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the averaged longitudinal strain of the left ventricle (%)	inter-group comparisons of the lowest values of the longitudinal strains of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction	2.5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the longitudinal strain of the left ventricle in apical long-axis view (%)	inter-group comparisons of the longitudinal strains of the left ventricle in apical long-xis view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction	2.5 minutes
the longitudinal strain of the left ventricle in apical 2 chamber view (%)	inter-group comparisons of the longitudinal strains of the left ventricle in apical 2 chamber view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction	2.5 minutes
the longitudinal strain of the left ventricle in apical 4 chamber view (%)	inter-group comparisons of the longitudinal strains of the left ventricle in apical 4 chamber view of the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction	2.5 minutes
the election fraction of the left ventricle	inter-group comparisons of the ejection fraction of the left ventricle in the transthoracic echocardiography after administering remimazolam- or propofol-administration for anesthesia induction	2.5 minutes

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Tae-Yop Kim, MD, PhD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 20210000-01

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