Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

Cardiac Surgery Clinical Trial

— SUPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851433
• Other study ID #: JAUDON-FAIVRE 2014
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2016
• Last updated: October 9, 2017
• Start date: October 14, 2015
• Est. completion date: September 4, 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 4, 2017
• Est. primary completion date: August 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• total anaesthesia and postoperative inhaled sedation with Sevoflurane

• total intravenous anaesthesia with Propofol.

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of troponin		Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level