Early Cardioprotective Effect of Sevoflurane - Tabular View

Tracking Information

First Received Date ^ICMJE

May 22, 2007

Last Updated Date

May 23, 2007

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00477737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Early Cardioprotective Effect of Sevoflurane

Official Title ^ICMJE

Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Coronary Artery Disease
Off Pump Coronary Artery Bypass Surgery

Intervention ^ICMJE

Drug: Sevoflurane
Drug: propofol

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Croatia

Administrative Information

NCT ID ^ICMJE

NCT00477737

Responsible Party

Study ID Numbers ^ICMJE

CARPRO10

Study Sponsor ^ICMJE

University Hospital Dubrava

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ino Husedzinovic, MD PhD Prof

Anesthesiology and Intensive Medicine

Information Provided By

University Hospital Dubrava

Verification Date

May 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP