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COMPLETED
NCT01294163
PHASE3

Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery

Sponsor: Air Liquide Santé International

View on ClinicalTrials.gov

Summary

Xenon is a gaseous anaesthetic agent registered in several European countries. It has been administered safely during cardiac surgery in pilot studies. In animal studies, xenon decreases the size of experimental myocardial infarction. 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.

Official title: Efficacy and Safety of Xenon Anaesthesia Compared to Sevoflurane Anaesthesia and Total Intravenous Anaesthesia for On-pump Coronary Artery Bypass Graft Surgery: a Randomised, Three-arm, Single-blind, International Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

509

Start Date

2011-04

Completion Date

2014-04

Last Updated

2026-07-22

Healthy Volunteers

No

Interventions

DRUG

Xenon

Inhaled xenon, maximal inspired concentration of 65%.

DRUG

Sevoflurane

Inhaled sevoflurane, maximal inspired concentration of 1.8%.

DRUG

Propofol

Hourly dose of 2-4 mg/kg

Locations (17)

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