NCT00477737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
Last Updated

May 24, 2007

Status Verified

May 1, 2007

First QC Date

May 22, 2007

Last Update Submit

May 23, 2007

Conditions

Keywords

cardioprotectionsevofluraneesophageal Dopplerthermodilutioncoronary artery bypass

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the degree I or II of Cardiac Anesthesia Risk Evaluation score
  • angiographically verified coronary artery disease
  • left ventricular ejection fraction higher than 40%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Ino Husedzinovic, MD PhD Prof

    Anesthesiology and Intensive Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 24, 2007

Study Start

August 1, 2006

Study Completion

December 1, 2006

Last Updated

May 24, 2007

Record last verified: 2007-05

Locations