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

This study has been completed.
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01294163
First received: February 9, 2011
Last updated: April 14, 2014
Last verified: April 2014

February 9, 2011
April 14, 2014
April 2011
April 2014   (final data collection date for primary outcome measure)
Blood level of troponin I [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Troponin I, sampling performed 24 hours after the end of the surgical procedure and measured by a central laboratory.
Blood level of troponin I [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Troponin I, sampling perfomed 24 hours after the end of the surgical procedure and measured by a central laboratory.
Complete list of historical versions of study NCT01294163 on ClinicalTrials.gov Archive Site
  • Depth of anaesthesia [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
  • Arterial oxygen saturation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Arterial blood gases
  • Haemodynamic profile [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Monitoring of heart rate, arterial blood pressure, central venous pressure.
  • Presence or absence of postoperative delirium [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Confusion Assessment Method
  • Clinical laboratory tests [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • ECG abnormalities [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Presence of absence of adverse events, including myocardial infarction [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • General Anesthetic Drug Allergy
  • Coronary Artery Bypass Graft Surgery
  • Drug: Xenon
    Inhaled xenon, maximal inspired concentration of 65%.
    Other Name: Xenon
  • Drug: Sevoflurane
    Inhaled sevoflurane, maximal inspired concentration of 1.8%.
    Other Name: Sevoflurane
  • Drug: Propofol
    Hourly dose of 2-4 mg/kg
    Other Name: Propofol
  • Experimental: Xenon
    Intervention: Drug: Xenon
  • Active Comparator: Sevoflurane
    Intervention: Drug: Sevoflurane
  • Active Comparator: Total intravenous anaesthesia
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
492
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Italy,   Netherlands
 
NCT01294163
ALMED-09-C3-026
No
Air Liquide Santé International
Air Liquide Santé International
Orion Corporation, Orion Pharma
Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands
Air Liquide Santé International
April 2014

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