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NCT Number: NCT00477737

Early Cardioprotective Effect of Sevoflurane

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Off Pump Coronary Artery Bypass Surgery Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Dubrava

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Propofol

Drug

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
May 24, 2007
Registry last updated
May 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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