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Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
This study has been completed.
Sponsor:
Air Liquide Santé International
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
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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 Intervention Model: Parallel Assignment Masking: Single (Participant) 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: 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
Secondary Outcome Measures:
- 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 ]
| 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%.
|
| Active Comparator: Sevoflurane |
Drug: Sevoflurane
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
|
| Active Comparator: Total intravenous anaesthesia |
Drug: Propofol
Hourly dose of 2-4 mg/kg
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01294163
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
| 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 |
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 Myocardial Ischemia Coronary Disease Drug Hypersensitivity Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Hypersensitivity Immune System Diseases Drug-Related Side Effects and Adverse Reactions |
Chemically-Induced Disorders Anesthetics Propofol Sevoflurane Xenon Central Nervous System Depressants Physiological Effects of Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Platelet Aggregation Inhibitors Anesthetics, Inhalation |
ClinicalTrials.gov processed this record on September 21, 2017