ClinicalTrials.gg
CompletedNCT00477737Updated May 24, 2007

Early Cardioprotective Effect of Sevoflurane

A Phase 4 interventional study of Sevoflurane and propofol in Coronary Artery Disease and Off Pump Coronary Artery Bypass Surgery, sponsored by University Hospital Dubrava. Completed at 1 site in Croatia. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-05-24.

Sponsored by University Hospital Dubrava · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Off Pump Coronary Artery Bypass Surgery

Keywords

  • cardioprotection
  • sevoflurane
  • esophageal Doppler
  • thermodilution
  • coronary artery bypass
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's enrollment of 32 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University Hospital Dubrava is the lead sponsor of 42 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
32 participants (actual)

Interventions

06

What researchers measure

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

07

Study locations

1 site
  • University Hospital Dubrava
    Zagreb, 10000, Croatia
08

References and documents

Publications

  • 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. PubMed 17589976 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00477737
Lead sponsor
University Hospital Dubrava
First posted
May 24, 2007
Start date
Aug 2006
Completion
Dec 2006
Last update
May 24, 2007

Study contacts

Ino Husedzinovic, MD PhD Prof
principal investigator · Anesthesiology and Intensive Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Sevoflurane

Start the discussion