Cardiac SurgeryPhase 4SUPRANCT02851433
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
A Phase 4 study testing total anaesthesia and postoperative inhaled sedation with Sevoflurane and total intravenous anaesthesia with Propofol. in people with Cardiac Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- total anaesthesia and postoperative inhaled sedation with Sevoflurane and total intravenous anaesthesia with Propofol.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2015to 4 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have provided informed written consent.
- Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
- Anterograde cardioplegia with cold blood
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery
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
- Being tested
- total anaesthesia and postoperative inhaled sedation with Sevoflurane, total intravenous anaesthesia with Propofol.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total anaesthesia and postoperative inhaled sedation with SevofluraneDrug
total intravenous anaesthesia with Propofol.Drug
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Experimental | Not described Receives: Drug: total anaesthesia and postoperative inhaled sedation with Sevoflurane |
| Propofol Group | Active comparator | Not described Receives: Drug: total intravenous anaesthesia with Propofol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of troponin
Measured: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start14 Oct 2015
- Primary completion29 Aug 2017
- Study completion4 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851433
- Sponsor's protocol ID
- JAUDON-FAIVRE 2014
- Acronym
- SUPRA
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
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.
PubMed 33327246
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Protective Effect of Conditioning With Sevoflurane Versus Propofol on the Myocardium in Scheduled Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT02851433
- Acronym / sponsor ID
- SUPRA / JAUDON-FAIVRE 2014
- Conditions
- Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 14 Oct 2015 (actual)
- Primary completion
- 29 Aug 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Experimental | Drug: total anaesthesia and postoperative inhaled sedation with Sevoflurane |
| Propofol Group | Active comparator | Drug: total intravenous anaesthesia with Propofol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have provided informed written consent.
- Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
- Anterograde cardioplegia with cold blood
Key exclusion criteria (12 listed)
- Adults under guardianship.
- Patients without national health insurance cover.
- Epileptics.
- Heart grafted patients.
- Patients under 18 years and pregnant or beast-feeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total anaesthesia and postoperative inhaled sedation with Sevoflurane | Drug | Sevoflurane Group |
| total intravenous anaesthesia with Propofol. | Drug | Propofol Group |
Primary outcome
Levels of troponin
Time frame: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 33327246Guinot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing total anaesthesia and postoperative inhaled sedation with Sevoflurane and total intravenous anaesthesia with Propofol. in people with Cardiac Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of troponin (time frame: Change at Hour 6, Hour 12, Hour 24, Hour 48 compared with baseline level). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02851433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.