Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
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
1 other identifier
interventional
509
4 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 coronary-artery-disease
Started Apr 2011
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
December 21, 2015
CompletedDecember 21, 2015
December 1, 2015
3 years
February 9, 2011
November 6, 2015
December 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Sampling performed 24 hours after the end of the surgical procedure
Log-transformed Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Sampling performed 24 hours after the end of the surgical procedure
Secondary Outcomes (8)
Depth of Anaesthesia
4 hours
Arterial Oxygen Saturation
4 hours
Haemodynamic Profile
4 hours
Presence or Absence of Postoperative Delirium
7 days
Clinical Laboratory Tests
7 days
- +3 more secondary outcomes
Study Arms (3)
Xenon
EXPERIMENTALSevoflurane
ACTIVE COMPARATORTotal intravenous anaesthesia
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnancy or child bearing potential
- ongoing treatment with nicorandil or sulfonylurea medication
- severe renal or hepatic dysfunction
- ongoing myocardial infarction or unstable angina
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Air Liquide Santé Internationallead
- Orion Corporation, Orion Pharmacollaborator
Study Sites (17)
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, 69677, France
CHU de Caen
Caen, 14033, France
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, 44093, France
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, 75013, France
Hôpital du Haut-Lévêque
Pessac, 33600, France
Hôpital Pontchaillou
Rennes, 35033, France
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091, France
Centre Hospitalier de Rangueil
Toulouse, 31059, France
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
University Hospital Aachen
Aachen, 52074, Germany
Klinikum Links der Weser - Senator-Wessling-Str. 1
Bremen, 28277, Germany
University Hospital Frankfurt AM Main
Frankfurt, 60590, Germany
UniversitatsKlinikum Schleswig-Holstein
Lübeck, 23538, Germany
University Hospital ROSTOCK
Rostock, 18057, Germany
Policlinico Umberto I
Rome, 00161, Italy
Academic Medical Center - University of Amsterdam
Amsterdam, 1100 DD, Netherlands
Thorax Center - Erasmus MC
Rotterdam, 3000 CA, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jan HOFLAND
- Organization
- Radboudumc, Department of Anaesthesiology
Study Officials
- PRINCIPAL INVESTIGATOR
Jan HOFLAND, MD, PhD
Thorax Centre Erasmus MC, Rotterdam, the Netherlands
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 11, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 21, 2015
Results First Posted
December 21, 2015
Record last verified: 2015-12