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Early Cardioprotective Effect of Sevoflurane
This study has been completed.
Study NCT00477737   Information provided by University Hospital Dubrava
First Received: May 22, 2007   Last Updated: May 23, 2007   History of Changes

May 22, 2007
May 23, 2007
August 2006
 
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 ]
Same as current
Complete list of historical versions of study NCT00477737 on ClinicalTrials.gov Archive Site
 
 
 
Early Cardioprotective Effect of Sevoflurane
Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart

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.

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.

Phase IV
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Coronary Artery Disease
  • Off Pump Coronary Artery Bypass Surgery
  • Drug: Sevoflurane
  • Drug: propofol
 
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.
 
Completed
32
December 2006
 

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT00477737
 
CARPRO10
University Hospital Dubrava
 
Principal Investigator: Ino Husedzinovic, MD PhD Prof Anesthesiology and Intensive Medicine
University Hospital Dubrava
May 2007

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