- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05041725
The Impact of Remimazolam for Postoperative Sedation on the Left Ventricular Systolic Performance in Cardiac Surgery
September 8, 2021 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center
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
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
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective off-pump coronary artery bypass surgery
Exclusion Criteria:
- arrhythmia
- LV ejection fraction < 50 %
- preoperative inotropic support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: remimazolam infusion
Intraoperative remimazolam infusion for postoperative sedation
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of the left ventricular global longitudinal strain
Time Frame: 1 minutes
|
mean values of the left ventricular global longitudinal strain after 3 minutes, 5 minutes and 10 minutes after the Remimazolam administration
|
1 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 1, 2021
Primary Completion (ANTICIPATED)
November 30, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
August 31, 2021
First Submitted That Met QC Criteria
September 8, 2021
First Posted (ACTUAL)
September 13, 2021
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210000-2
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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