Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

NCT02851433 | Completed Phase 4

• 1 other identifier: JAUDON-FAIVRE 2014
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Levels of troponin

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

Study Arms (2)

Sevoflurane Group

EXPERIMENTAL

Drug: total anaesthesia and postoperative inhaled sedation with Sevoflurane

Propofol Group

ACTIVE COMPARATOR

Drug: total intravenous anaesthesia with Propofol.

Interventions

total anaesthesia and postoperative inhaled sedation with Sevoflurane DRUG

Sevoflurane Group

total intravenous anaesthesia with Propofol. DRUG

Propofol Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

• Guinot PG, Ellouze O, Grosjean S, Berthoud V, Constandache T, Radhouani M, Anciaux JB, Aho-Glele S, Morgant MC, Girard C, Nguyen M, Bouhemad B. Anaesthesia and ICU sedation with sevoflurane do not reduce myocardial injury in patients undergoing cardiac surgery: A randomized prospective study. Medicine (Baltimore). 2020 Dec 11;99(50):e23253. doi: 10.1097/MD.0000000000023253.

  PMID: 33327246 RESULT

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: October 14, 2015
• Primary Completion: August 29, 2017
• Study Completion: September 4, 2017
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)