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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

Tracking Information
First Submitted Date  ICMJE February 9, 2011
First Posted Date  ICMJE February 11, 2011
Results First Submitted Date  ICMJE November 6, 2015
Results First Posted Date  ICMJE December 21, 2015
Last Update Posted Date December 21, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
Blood Level of Troponin I [ Time Frame: 1 day ]
Troponin I, sampling perfomed 24 hours after the end of the surgical procedure and measured by a central laboratory.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2011)
  • Depth of Anaesthesia [ Time Frame: 4 hours ]
    On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
  • Arterial Oxygen Saturation [ Time Frame: 4 hours ]
    Arterial blood gases
  • Haemodynamic Profile [ Time Frame: 4 hours ]
    Monitoring of heart rate, arterial blood pressure, central venous pressure.
  • Presence or Absence of Postoperative Delirium [ Time Frame: 7 days ]
    Confusion Assessment Method
  • Clinical Laboratory Tests [ Time Frame: 7 days ]
  • ECG Abnormalities [ Time Frame: 7 days ]
  • Vital Signs [ Time Frame: 7 days ]
  • Presence of Absence of Adverse Events, Including Myocardial Infarction [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • General Anesthetic Drug Allergy
  • Coronary Artery Bypass Graft Surgery
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Xenon
    Intervention: Drug: Xenon
  • Active Comparator: Sevoflurane
    Intervention: Drug: Sevoflurane
  • Active Comparator: Total intravenous anaesthesia
    Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2014)
509
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2011)
492
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01294163
Other Study ID Numbers  ICMJE ALMED-09-C3-026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Air Liquide Santé International
Study Sponsor  ICMJE Air Liquide Santé International
Collaborators  ICMJE Orion Corporation, Orion Pharma
Investigators  ICMJE
Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands
PRS Account Air Liquide Santé International
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP