Early Cardioprotective Effect of Sevoflurane
Information source: University Hospital Dubrava
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease; Off Pump Coronary Artery Bypass Surgery
Intervention: Sevoflurane (Drug); propofol (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital Dubrava Official(s) and/or principal investigator(s):
Ino Husedzinovic, MD PhD Prof, Principal Investigator, Affiliation: Anesthesiology and Intensive Medicine
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.
Clinical Details
Official title: Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate cardiac function with measuring of hemodynamic parameters
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.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
University Hospital Dubrava, Zagreb 10000, Croatia
Additional Information
Starting date: August 2006
Ending date: December 2006
Last updated: May 23, 2007
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