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 22, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
General Anesthetic Drug Allergy
Coronary Artery Bypass Graft Surgery
Drug: Xenon
Drug: Sevoflurane
Drug: Propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 509
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenon Drug: Xenon
Inhaled xenon, maximal inspired concentration of 65%.
Other Name: Xenon
Active Comparator: Sevoflurane Drug: Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
Other Name: Sevoflurane
Active Comparator: Total intravenous anaesthesia Drug: Propofol
Hourly dose of 2-4 mg/kg
Other Name: Propofol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294163

Locations
France
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, France, 69677
CHU de Caen
Caen, France, 14033
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, France, 44093
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, France, 75013
Hôpital du Haut-Lévêque
Pessac, France, 33600
Hôpital Pontchaillou
Rennes, France, 35033
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
Centre Hospitalier de Rangueil
Toulouse, France, 31059
Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
University Hospital Aachen
Aachen, Germany, 52074
Klinikum Links der Weser - Senator-Wessling-Str. 1
Bremen, Germany, 28277
University Hospital Frankfurt AM Main
Frankfurt, Germany, 60590
UniversitatsKlinikum Schleswig-Holstein
Lubeck, Germany, 23538
University Hospital ROSTOCK
Rostock, Germany, 18057
Italy
Policlinico Umberto I
Rome, Italy, 00161
Netherlands
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands, 1100 DD
Thorax Center - Erasmus MC
Rotterdam, Netherlands, 3000 CA
Sponsors and Collaborators
Air Liquide Santé International
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Jan HOFLAND, MD, PhD Thorax Centre Erasmus MC, Rotterdam, the Netherlands
  More Information

No publications provided

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
Last Updated: April 22, 2014
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)

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:
Coronary Artery Disease
Coronary Disease
Drug Hypersensitivity
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Heart Diseases
Hypersensitivity
Immune System Diseases
Vascular Diseases
Anesthetics
Propofol
Sevoflurane
Xenon
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014