Clinical trial NCT00477737: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Off Pump Coronary Artery Bypass Surgery
Keywords: cardioprotection
sevoflurane
esophageal Doppler
thermodilution
coronary artery bypass
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate cardiac function with measuring of hemodynamic parameters
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: Anesthesiology and Intensive Medicine
name: Ino Husedzinovic, MD PhD Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.