- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02222142
Volatile Versus Propofol Anesthesia in OPCAB
August 20, 2014 updated by: Jong Hwan Lee, Samsung Medical Center
Comparison of Propofol and Isoflurane Anesthesia on Cardioprotection and Clinical Outcomes in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery : A Propensity-score Analysis
Off pump coronary artery bypass graft (OPCAB) still requires myocardial protection owing to intermittent regional ischemic episode.
The investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect.
Off-pump coronary artery bypass graft (OPCAB) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis.
The aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing OPCAB using propensity matching.
Study Type
Observational
Enrollment (Actual)
1080
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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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
Sampling Method
Non-Probability Sample
Study Population
patients underwent OPCAB from January, 2010 to December, 2012
Description
Inclusion Criteria:
- OPCAB
Exclusion Criteria:
- On pump conversion
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Isoflurane group
Isoflurane inhalational anesthesia during OPCAB
|
Comparison between isoflurane and propofol, Retrospective study
Other Names:
|
Propofol group
Total intravenous anesthesia with propofol during OPCAB
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CK-MB, CRP
Time Frame: Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
|
Comparison of CK-MB and CRP values between propofol and isoflurane groups on postoperative day, POD1 and POD 2
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Change from preoperative value in CK-MR and CRP at Postoperative day(POD), POD 1 and 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical adverse outcomes
Time Frame: until 1 year after OPCAB
|
clinical adverse outcomes until postoperative 1 year
|
until 1 year after OPCAB
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardioprotection and clinical adverse outcomes in diabetic patients
Time Frame: POD, POD 1, POD 2, one month, one year
|
primary and secondary outcome analysis in diabetic patients
|
POD, POD 1, POD 2, one month, one year
|
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
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
August 17, 2014
First Submitted That Met QC Criteria
August 20, 2014
First Posted (Estimate)
August 21, 2014
Study Record Updates
Last Update Posted (Estimate)
August 21, 2014
Last Update Submitted That Met QC Criteria
August 20, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-09-127
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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