Early Cardioprotective Effect of Sevoflurane

Phase 4

Completed

• Conditions: Coronary Artery Disease; Off Pump Coronary Artery Bypass Surgery

• Registration Number: NCT00477737
• Lead Sponsor: University Hospital Dubrava

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.

Study Timeline

• Study Start: 2006-08
• Study Completion: 2006-12
• Status Verified: 2007-05
• Study First Submitted: 2007-05-22
• Study First Submitted QC: 2007-05-23
• Last Update Submitted: 2007-05-23
• Study First Posted: 2007-05-24
• Last Update Posted: 2007-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate cardiac function with measuring of hemodynamic parameters	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

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia