Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium
NCT ID: NCT02851433
Last Updated: 2017-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2015-10-14
2017-09-04
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sevoflurane Group
total anaesthesia and postoperative inhaled sedation with Sevoflurane
Propofol Group
total intravenous anaesthesia with Propofol.
Interventions
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total anaesthesia and postoperative inhaled sedation with Sevoflurane
total intravenous anaesthesia with Propofol.
Eligibility Criteria
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Inclusion Criteria
* Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
* Anterograde cardioplegia with cold blood
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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JAUDON-FAIVRE 2014
Identifier Type: -
Identifier Source: org_study_id