Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
NCT ID: NCT01294163
Last Updated: 2015-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
509 participants
INTERVENTIONAL
2011-04-30
2014-04-30
Brief Summary
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This 3-arm study will compare xenon, sevoflurane and a propofol-based total intravenous anaesthesia for maintenance of anaesthesia during coronary artery bypass graft surgery conducted with extra-corporeal circulation. Xenon and sevoflurane will be administered before and after extracorporeal circulation. Propofol will be administered during extracorporeal circulation in the three groups of patients.
The study will compare the postoperative myocardial damage observed 24 hours after surgery from blood levels of troponin I, a largely accepted biomarker of myocardial necrosis. The main hypothesis is that the myocardial damage observed after xenon administration will not be superior to the damage observed after sevoflurane administration (non-inferiority). The second hypothesis is that the myocardial damage observed after xenon administration will be inferior to the damage observed after total intravenous anaesthesia.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Xenon
Xenon
Inhaled xenon, maximal inspired concentration of 65%.
Sevoflurane
Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Total intravenous anaesthesia
Propofol
Hourly dose of 2-4 mg/kg
Interventions
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Xenon
Inhaled xenon, maximal inspired concentration of 65%.
Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Propofol
Hourly dose of 2-4 mg/kg
Eligibility Criteria
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Inclusion Criteria
* elective surgery, planned coronary artery bypass graft
* moderate hypothermia or normothermia
* cardiac arrest cold and warm cardioplegia
* normal of moderately impaired left ventricular systolic function
* written informed consent
Exclusion Criteria
* ongoing treatment with nicorandil or sulfonylurea medication
* severe renal or hepatic dysfunction
* ongoing myocardial infarction or unstable angina
18 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Air Liquide Santé International
INDUSTRY
Responsible Party
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Principal Investigators
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Jan HOFLAND, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Thorax Centre Erasmus MC, Rotterdam, the Netherlands
Locations
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Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, , France
CHU de Caen
Caen, , France
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, , France
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, , France
Hôpital du Haut-Lévêque
Pessac, , France
Hôpital Pontchaillou
Rennes, , France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, , France
Centre Hospitalier de Rangueil
Toulouse, , France
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
University Hospital Aachen
Aachen, , Germany
Klinikum Links der Weser - Senator-Wessling-Str. 1
Bremen, , Germany
University Hospital Frankfurt AM Main
Frankfurt, , Germany
UniversitatsKlinikum Schleswig-Holstein
Lübeck, , Germany
University Hospital ROSTOCK
Rostock, , Germany
Policlinico Umberto I
Rome, , Italy
Academic Medical Center - University of Amsterdam
Amsterdam, , Netherlands
Thorax Center - Erasmus MC
Rotterdam, , Netherlands
Countries
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Other Identifiers
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ALMED-09-C3-026
Identifier Type: -
Identifier Source: org_study_id