Early Cardioprotective Effect of Sevoflurane

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477737
• Other study ID #: CARPRO10
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2007
• Last updated: May 23, 2007
• Start date: August 2006
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Off Pump Coronary Artery Bypass Surgery

Intervention

Drug:
• Sevoflurane

• propofol

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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