Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium (SUPRA)

February 4, 2026 updated by: Centre Hospitalier Universitaire Dijon

Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery

Heart surgery is a considerable source of stress for the myocardium that must be minimized.

Troponin Ic is a reliable marker to determine the level of this myocardial stress.

Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.

The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have provided informed written consent.
  • Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
  • Anterograde cardioplegia with cold blood

Exclusion Criteria:

  • Adults under guardianship.
  • Patients without national health insurance cover.
  • Epileptics.
  • Heart grafted patients.
  • Patients under 18 years and pregnant or beast-feeding women.
  • Aortic dissections and vascular surgery.
  • Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent
  • Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.
  • pre-operative LVEF<35%.
  • Coronary artery bypass graft alone or associated.
  • Mitral valve replacements.
  • Warm cardioplegia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevoflurane Group
Drug: total anaesthesia and postoperative inhaled sedation with Sevoflurane
Active Comparator: Propofol Group
Drug: total intravenous anaesthesia with Propofol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of troponin
Time Frame: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level
Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2015

Primary Completion (Actual)

August 29, 2017

Study Completion (Actual)

September 4, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (Estimated)

August 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JAUDON-FAIVRE 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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