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Early Cardioprotective Effect of Sevoflurane

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ClinicalTrials.gov Identifier: NCT00477737
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : May 24, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Off Pump Coronary Artery Bypass Surgery Drug: Sevoflurane Drug: propofol Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Early Cardioprotective Effect of Sevoflurane on Left Ventricular Performance During Coronary Artery Bypass Grafting on a Beating Heart
Study Start Date : August 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00477737     History of Changes
Other Study ID Numbers: CARPRO10
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: May 24, 2007
Last Verified: May 2007

Keywords provided by University Hospital Dubrava:
cardioprotection
sevoflurane
esophageal Doppler
thermodilution
coronary artery bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation