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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Remimazolam Injection [Byfavo]
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective off-pump coronary artery bypass surgery

Exclusion Criteria:

  • arrhythmia
  • LV ejection fraction < 50 %
  • preoperative inotropic support

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    remimazolam infusion

    Arm Description

    Intraoperative remimazolam infusion for postoperative sedation

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    September 8, 2021
    Sponsor
    Konkuk University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05041725
    Brief Title
    The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Konkuk University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    remimazolam infusion
    Arm Type
    Experimental
    Arm Description
    Intraoperative remimazolam infusion for postoperative sedation
    Intervention Type
    Drug
    Intervention Name(s)
    Remimazolam Injection [Byfavo]
    Other Intervention Name(s)
    Remimazolam infusion
    Intervention Description
    Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour
    Primary Outcome Measure Information:
    Title
    change of the left ventricular global longitudinal strain
    Description
    mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration
    Time Frame
    1 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elective off-pump coronary artery bypass surgery Exclusion Criteria: arrhythmia LV ejection fraction < 50 % preoperative inotropic support

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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