Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02851433

Acronym

SUPRA

Enrollment

Registered

2016-08-01

Start date

2015-10-14

Completion date

2017-09-04

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

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.

Interventions

DRUGtotal anaesthesia and postoperative inhaled sedation with Sevoflurane

DRUGtotal intravenous anaesthesia with Propofol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026