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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: December 18, 2015
Last verified: December 2015
Results First Received: November 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Coronary Artery Disease
General Anesthetic Drug Allergy
Coronary Artery Bypass Graft Surgery
Interventions: Drug: Xenon
Drug: Sevoflurane
Drug: Propofol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

A total of 542 patients were enrolled (509 met the inclusion criteria) from 17 centres in 4 countries; 8 sites in France, 6 sites in Germany, 1 site in Italy and 2 sites in The Netherlands.

Date of first enrolment: 20 April 2011 Date of last completed: 05 April 2014


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Xenon Including Pilot Patients Anesthetic agent before and after CPB: xenon
Sevoflurane Anesthetic agent before and after CPB: sevoflurane
TIVA Anesthetic agent before and after CPB: propofol

Participant Flow:   Overall Study
    Xenon Including Pilot Patients     Sevoflurane     TIVA  
STARTED     178     165     166  
COMPLETED     177     165     163  
NOT COMPLETED     1     0     3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): randomised and treated patients

Reporting Groups
  Description
Xenon Anesthetic agent before and after CPB: xenon
Sevoflurane Anesthetic agent before and after CPB: sevoflurane
TIVA Anesthetic agent before and after CPB: propofol
Total Total of all reporting groups

Baseline Measures
    Xenon     Sevoflurane     TIVA     Total  
Number of Participants  
[units: participants]
  161     165     166     492  
Age  
[units: years]
Mean (Standard Deviation)
  64.66  (9.12)     63.86  (8.66)     63.89  (9.40)     64.14  (9.06)  
Gender  
[units: participants]
       
Female     19     25     20     64  
Male     142     140     146     428  
Region of Enrollment  
[units: participants]
       
Netherlands     12     11     11     34  
Italy     3     4     4     11  
France     89     93     93     275  
Germany     57     57     58     172  
BMI  
[units: kg/m²]
Mean (Standard Deviation)
  27.65  (3.64)     27.21  (3.68)     27.78  (4.00)     27.55  (3.78)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Blood Level of Troponin I   [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]

2.  Primary:   Log-transformed Blood Level of Troponin I   [ Time Frame: Sampling performed 24 hours after the end of the surgical procedure ]

3.  Secondary:   Depth of Anaesthesia   [ Time Frame: 4 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Arterial Oxygen Saturation   [ Time Frame: 4 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Haemodynamic Profile   [ Time Frame: 4 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Presence or Absence of Postoperative Delirium   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Clinical Laboratory Tests   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   ECG Abnormalities   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Vital Signs   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   Presence of Absence of Adverse Events, Including Myocardial Infarction   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Jan HOFLAND
Organization: Radboudumc, Department of Anaesthesiology
phone: +31243611111 ext 3658
e-mail: Jan.Hofland@radboudumc.nl



Responsible Party: Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT01294163     History of Changes
Other Study ID Numbers: ALMED-09-C3-026
Study First Received: February 9, 2011
Results First Received: November 6, 2015
Last Updated: December 18, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Institute of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)