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
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
NCT ID
NCT05041725
First Posted
August 31, 2021
Last Updated
September 8, 2021
Sponsor
Konkuk University Medical Center
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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