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

Primary Purpose

Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xenon
Sevoflurane
Propofol
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Xenon, Sevoflurane, Propofol, Total intravenous anaesthesia, Anaesthesia, Coronary artery disease, Coronary artery bypass graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Cardiovasculaire et Pneumologique Louis Pradel
  • CHU de Caen
  • Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
  • Centre Hospitalo-Universitaire Pitié-Salpetrière
  • Hôpital du Haut-Lévêque
  • Hôpital Pontchaillou
  • Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
  • Centre Hospitalier de Rangueil
  • Universitätsklinikum Schleswig-Holstein
  • University Hospital Aachen
  • Klinikum Links der Weser - Senator-Wessling-Str. 1
  • University Hospital Frankfurt AM Main
  • UniversitatsKlinikum Schleswig-Holstein
  • University Hospital ROSTOCK
  • Policlinico Umberto I
  • Academic Medical Center - University of Amsterdam
  • Thorax Center - Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Xenon

Sevoflurane

Total intravenous anaesthesia

Arm Description

Outcomes

Primary Outcome Measures

Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Log-transformed Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory

Secondary Outcome Measures

Depth of Anaesthesia
On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
Arterial Oxygen Saturation
Arterial blood gases
Haemodynamic Profile
Monitoring of heart rate, arterial blood pressure, central venous pressure.
Presence or Absence of Postoperative Delirium
Confusion Assessment Method
Clinical Laboratory Tests
ECG Abnormalities
Vital Signs
Presence of Absence of Adverse Events, Including Myocardial Infarction

Full Information

First Posted
February 9, 2011
Last Updated
December 18, 2015
Sponsor
Air Liquide Santé International
Collaborators
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01294163
Brief Title
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide Santé International
Collaborators
Orion Corporation, Orion Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
Keywords
Xenon, Sevoflurane, Propofol, Total intravenous anaesthesia, Anaesthesia, Coronary artery disease, Coronary artery bypass graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenon
Arm Type
Experimental
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm Title
Total intravenous anaesthesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
Inhaled xenon, maximal inspired concentration of 65%.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Hourly dose of 2-4 mg/kg
Primary Outcome Measure Information:
Title
Blood Level of Troponin I
Description
Blood level of troponin I measured by a central laboratory
Time Frame
Sampling performed 24 hours after the end of the surgical procedure
Title
Log-transformed Blood Level of Troponin I
Description
Blood level of troponin I measured by a central laboratory
Time Frame
Sampling performed 24 hours after the end of the surgical procedure
Secondary Outcome Measure Information:
Title
Depth of Anaesthesia
Description
On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
Time Frame
4 hours
Title
Arterial Oxygen Saturation
Description
Arterial blood gases
Time Frame
4 hours
Title
Haemodynamic Profile
Description
Monitoring of heart rate, arterial blood pressure, central venous pressure.
Time Frame
4 hours
Title
Presence or Absence of Postoperative Delirium
Description
Confusion Assessment Method
Time Frame
7 days
Title
Clinical Laboratory Tests
Time Frame
7 days
Title
ECG Abnormalities
Time Frame
7 days
Title
Vital Signs
Time Frame
7 days
Title
Presence of Absence of Adverse Events, Including Myocardial Infarction
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan HOFLAND, MD, PhD
Organizational Affiliation
Thorax Centre Erasmus MC, Rotterdam, the Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Hospitalo-Universitaire Pitié-Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital du Haut-Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinikum Links der Weser - Senator-Wessling-Str. 1
City
Bremen
ZIP/Postal Code
28277
Country
Germany
Facility Name
University Hospital Frankfurt AM Main
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
UniversitatsKlinikum Schleswig-Holstein
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
University Hospital ROSTOCK
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Policlinico Umberto I
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Academic Medical Center - University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Facility Name
Thorax Center - Erasmus MC
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands

12. IPD Sharing Statement

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

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