Early Cardioprotective Effect of Sevoflurane - Full Text View

Sponsor:	University Hospital Dubrava
Information provided by:	University Hospital Dubrava
ClinicalTrials.gov Identifier:	NCT00477737

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease Off Pump Coronary Artery Bypass Surgery	Drug: Sevoflurane Drug: propofol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Coronary Artery Bypass Surgery Coronary Artery Disease Surgery

Drug Information available for: Sevoflurane Propofol

U.S. FDA Resources

Further study details as provided by University Hospital Dubrava:

Primary Outcome Measures:

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 ]

Enrollment:	32
Study Start Date:	August 2006
Study Completion Date:	December 2006

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

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477737

Locations

Croatia
University Hospital Dubrava
Zagreb, Croatia, 10000

Sponsors and Collaborators

University Hospital Dubrava

Investigators

Principal Investigator:

Ino Husedzinovic, MD PhD Prof

Anesthesiology and Intensive Medicine

More Information

No publications provided by University Hospital Dubrava

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	CARPRO10
Study First Received:	May 22, 2007
Last Updated:	May 23, 2007
ClinicalTrials.gov Identifier:	NCT00477737 History of Changes
Health Authority:	Croatia: Ministry of Health and Social Care

Keywords provided by University Hospital Dubrava:

cardioprotection
sevoflurane
esophageal Doppler
thermodilution
coronary artery bypass

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Vascular Diseases
Central Nervous System Depressants
Anesthetics
Arteriosclerosis
Pharmacologic Actions

Sevoflurane
Coronary Disease
Anesthetics, Inhalation
Anesthetics, General
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 27, 2009