Clinical trial NCT01294163: Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
General Anesthetic Drug Allergy
Coronary Artery Bypass Graft Surgery
Keywords: Xenon
Sevoflurane
Propofol
Total intravenous anaesthesia
Anaesthesia
Coronary artery disease
Coronary artery bypass graft
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2011-02-11
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* 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:

* pregnancy or child bearing potential
* ongoing treatment with nicorandil or sulfonylurea medication
* severe renal or hepatic dysfunction
* ongoing myocardial infarction or unstable angina

Primary outcomes:
measure: Blood Level of Troponin I
timeFrame: Sampling performed 24 hours after the end of the surgical procedure
measure: Log-transformed Blood Level of Troponin I
timeFrame: Sampling performed 24 hours after the end of the surgical procedure
Secondary outcomes:
measure: Depth of Anaesthesia
timeFrame: 4 hours
measure: Arterial Oxygen Saturation
timeFrame: 4 hours
measure: Haemodynamic Profile
timeFrame: 4 hours
measure: Presence or Absence of Postoperative Delirium
timeFrame: 7 days
measure: Clinical Laboratory Tests
timeFrame: 7 days
measure: ECG Abnormalities
timeFrame: 7 days
measure: Vital Signs
timeFrame: 7 days
measure: Presence of Absence of Adverse Events, Including Myocardial Infarction
timeFrame: 7 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel
city: Caen
country: France
facility: CHU de Caen
city: Nantes
country: France
facility: Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Centre Hospitalo-Universitaire Pitié-Salpetrière
city: Pessac
country: France
facility: Hôpital du Haut-Lévêque
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Centre Hospitalier de Rangueil
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: University Hospital Aachen
city: Bremen
country: Germany
facility: Klinikum Links der Weser - Senator-Wessling-Str. 1
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt AM Main
city: Lubeck
country: Germany
facility: UniversitatsKlinikum Schleswig-Holstein
city: Rostock
country: Germany
facility: University Hospital ROSTOCK
city: Rome
country: Italy
facility: Policlinico Umberto I
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
city: Rotterdam
country: Netherlands
facility: Thorax Center - Erasmus MC
Study officials:
affiliation: Thorax Centre Erasmus MC, Rotterdam, the Netherlands
name: Jan HOFLAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: