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The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05041725
Collaborator
(none)
15
Enrollment
1
Arm
14
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study analyzes the impact of intraoperative Remimazolam infusion for postoperative sedation on the left ventricular global longitude strain (LV-GLS) patients undergoing cardiac surgery

Condition or Disease Intervention/Treatment Phase
  • Drug: Remimazolam Injection [Byfavo]
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of Remimazolam on the Left Ventricular Systolic Performance for Cardiac Surgery: a Speckle Tracking Analysis of the Left Ventricular Strain Using Transthoracic Echocardiography
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: remimazolam infusion

Intraoperative remimazolam infusion for postoperative sedation

Drug: Remimazolam Injection [Byfavo]
Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour
Other Names:
  • Remimazolam infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change of the left ventricular global longitudinal strain [1 minutes]

      mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • elective off-pump coronary artery bypass surgery
    Exclusion Criteria:

    • arrhythmia

    • LV ejection fraction < 50 %

    • preoperative 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:
    NCT05041725
    Other Study ID Numbers:
    • 20210000-2
    First Posted:
    Sep 13, 2021
    Last Update Posted:
    Sep 13, 2021
    Last Verified:
    Sep 1, 2021
    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:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Sep 13, 2021