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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01294163
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Air Liquide Santé International

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease General Anesthetic Drug Allergy Coronary Artery Bypass Graft Surgery Drug: Xenon Drug: Sevoflurane Drug: Propofol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 509 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Xenon Drug: Xenon
Inhaled xenon, maximal inspired concentration of 65%.

Active Comparator: Sevoflurane Drug: Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.

Active Comparator: Total intravenous anaesthesia Drug: Propofol
Hourly dose of 2-4 mg/kg

Primary Outcome Measures :
  1. Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]
    Blood level of troponin I measured by a central laboratory

  2. Log-transformed Blood Level of Troponin I [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]
    Blood level of troponin I measured by a central laboratory

Secondary Outcome Measures :
  1. Depth of Anaesthesia [ Time Frame: 4 hours ]
    On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)

  2. Arterial Oxygen Saturation [ Time Frame: 4 hours ]
    Arterial blood gases

  3. Haemodynamic Profile [ Time Frame: 4 hours ]
    Monitoring of heart rate, arterial blood pressure, central venous pressure.

  4. Presence or Absence of Postoperative Delirium [ Time Frame: 7 days ]
    Confusion Assessment Method

  5. Clinical Laboratory Tests [ Time Frame: 7 days ]
  6. ECG Abnormalities [ Time Frame: 7 days ]
  7. Vital Signs [ Time Frame: 7 days ]
  8. Presence of Absence of Adverse Events, Including Myocardial Infarction [ Time Frame: 7 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01294163

Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, France, 69677
CHU de Caen
Caen, France, 14033
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, France, 75013
Hôpital du Haut-Lévêque
Pessac, France, 33600
Hôpital Pontchaillou
Rennes, France, 35033
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Centre Hospitalier de Rangueil
Toulouse, France, 31059
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
University Hospital Aachen
Aachen, Germany, 52074
Klinikum Links der Weser - Senator-Wessling-Str. 1
Bremen, Germany, 28277
University Hospital Frankfurt AM Main
Frankfurt, Germany, 60590
UniversitatsKlinikum Schleswig-Holstein
Lubeck, Germany, 23538
University Hospital ROSTOCK
Rostock, Germany, 18057
Policlinico Umberto I
Rome, Italy, 00161
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1100 DD
Thorax Center - Erasmus MC
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Air Liquide Santé International
Orion Corporation, Orion Pharma
Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands

Responsible Party: Air Liquide Santé International Identifier: NCT01294163     History of Changes
Other Study ID Numbers: ALMED-09-C3-026
First Posted: February 11, 2011    Key Record Dates
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Air Liquide Santé International:
Total intravenous anaesthesia
Coronary artery disease
Coronary artery bypass graft

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Drug Hypersensitivity
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation