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

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ClinicalTrials.gov Identifier: NCT01294163
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Air Liquide Santé International

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01294163


Locations
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Sponsors and Collaborators
Air Liquide Santé International
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands
More Information
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Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01294163    
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:
Xenon
Sevoflurane
Propofol
Total intravenous anaesthesia
 Anaesthesia
Coronary artery disease
Coronary artery bypass graft
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Drug Hypersensitivity
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
 Chemically-Induced Disorders
Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation