Early Cardioprotective Effect of Sevoflurane
Primary Purpose
Coronary Artery Disease, Off Pump Coronary Artery Bypass Surgery
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Sevoflurane
propofol
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardioprotection, sevoflurane, esophageal Doppler, thermodilution, coronary artery bypass
Eligibility Criteria
Inclusion Criteria:
- the degree I or II of Cardiac Anesthesia Risk Evaluation score
- angiographically verified coronary artery disease
- left ventricular ejection fraction higher than 40%
Exclusion Criteria:
- atrioventricular conduction disturbances
- previously ventricular arrhythmias requiring antiarrhythmic treatment
- atrial fibrillation with rapid ventricular response
- myocardial infarction or stroke within 6 months
- diabetes mellitus
- end-stage of obstructive or restrictive pulmonary disease
Sites / Locations
- University Hospital Dubrava
Outcomes
Primary Outcome Measures
To evaluate cardiac function with measuring of hemodynamic parameters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00477737
Brief Title
Early Cardioprotective Effect of Sevoflurane
Official Title
Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Dubrava
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In vitro studies and in vivo animal experiments have shown that halogenated volatile anesthetics have a protective effect on the ischemic myocardium. In clinical settings however, anesthetic preconditioning may be of more interest. The aim of our study was to evaluate the cardioprotective effect of sevoflurane in patients undergoing off-pump coronary artery bypass surgery. We proposed that a cardioprotective effect of sevoflurane would save myocardial function, which we measured acceleration by esophageal Doppler and cardiac index with bolus thermodilution methods, both during brief ischemia and reperfusion.
Detailed Description
Studies have been performed on human patients undergoing CABG surgery with cardiopulmonary bypass (CPB). Only a few studies however have evaluated the effects of volatile anesthetics during coronary artery bypass grafting on a beating heart (OPCABG) with conflicting results as far as cardiac biomarker release is concerned.
Because CPB is known to have a profound impact on cardiac function, studies performed on patients scheduled for OPCABG could evaluate more specifically the effects of the anesthetic agents themselves. Patients undergoing OPCABG have a predictable and predefined ischemic zone during surgery and represent an extremely interesting and safe model for the study of ischemia and cardiac damage in humans.
Presently, there is still no consensus on the method of administration of volatile anesthetics, including the time to begin administration, its duration, the dosage and selection of volatile anesthetics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Off Pump Coronary Artery Bypass Surgery
Keywords
cardioprotection, sevoflurane, esophageal Doppler, thermodilution, coronary artery bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Type
Drug
Intervention Name(s)
propofol
Primary Outcome Measure Information:
Title
To evaluate cardiac function with measuring of hemodynamic parameters
Time Frame
Measurements were performed at the following intervals: 5 minutes after anesthesia induction; at the beginning of ischemia; 15 minutes after ischemia; 15 minutes after sternum closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the degree I or II of Cardiac Anesthesia Risk Evaluation score
angiographically verified coronary artery disease
left ventricular ejection fraction higher than 40%
Exclusion Criteria:
atrioventricular conduction disturbances
previously ventricular arrhythmias requiring antiarrhythmic treatment
atrial fibrillation with rapid ventricular response
myocardial infarction or stroke within 6 months
diabetes mellitus
end-stage of obstructive or restrictive pulmonary disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ino Husedzinovic, MD PhD Prof
Organizational Affiliation
Anesthesiology and Intensive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17589976
Citation
Huseidzinovic I, Barisin S, Bradic N, Milanovic R. Early cardioprotective effect of sevoflurane on left ventricular performance during coronary artery bypass grafting on a beating heart: randomized controlled study. Croat Med J. 2007 Jun;48(3):333-40.
Results Reference
derived
Learn more about this trial
Early Cardioprotective Effect of Sevoflurane
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