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

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05412914
Collaborator
(none)
40
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Remimazolam infusion
  • Drug: Propofol infusion
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
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
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. the longitudinal strain change of the left ventricle (%) [every 5 min]

      inter-group comparisons of the lowest values of the longitudinal strains of the left ventricle in the transesophageal echocardiography after the start of remimazolam- or propofol-administration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • left ventricular ejection fraction> 50%

    • no left ventricular regional wall motion abnormality

    Exclusion Criteria:

    • atrial fibrillation

    • unfavorable airway

    • hypotension requiring inotropic support

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Konkuk University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tae-Yop Kim, MD PhD, Professor, Department of Anesthesiology, Konkuk University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05412914
    Other Study ID Numbers:
    • 20210000-01
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Propofol

    Study Results

    No Results Posted as of Jun 9, 2022