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Clinical Trials/NCT02851433
NCT02851433
Completed
Phase 4

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

Centre Hospitalier Universitaire Dijon1 site in 1 country82 target enrollmentOctober 14, 2015

Overview

Phase
Phase 4
Intervention
total anaesthesia and postoperative inhaled sedation with Sevoflurane
Conditions
Cardiac Surgery
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
82
Locations
1
Primary Endpoint
Levels of troponin
Status
Completed
Last Updated
2 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2015
End Date
September 4, 2017
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Sevoflurane Group

Intervention: total anaesthesia and postoperative inhaled sedation with Sevoflurane

Propofol Group

Intervention: total intravenous anaesthesia with Propofol.

Outcomes

Primary Outcomes

Levels of troponin

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

Study Sites (1)

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