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Completed

NCT Number: NCT02851433

Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

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.

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Key information

Conditions

Cardiac Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

total anaesthesia and postoperative inhaled sedation with Sevoflurane

Drug

total intravenous anaesthesia with Propofol.

Drug

Primary outcomes

  1. Levels of troponin

    Time frame: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: SUPRA

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 1, 2016
Registry last updated
Feb 6, 2026

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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