Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
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ClinicalTrials.gov Identifier: NCT01294163 |
Recruitment Status :
Completed
First Posted : February 11, 2011
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease General Anesthetic Drug Allergy Coronary Artery Bypass Graft Surgery | Drug: Xenon Drug: Sevoflurane Drug: Propofol | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 509 participants |
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 |
Study Start Date : | April 2011 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- 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
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294163

Principal Investigator: | Jan HOFLAND, MD, PhD | Thorax Centre Erasmus MC, Rotterdam, the Netherlands |
Responsible Party: | Air Liquide Santé International |
ClinicalTrials.gov Identifier: | NCT01294163 |
Other Study ID Numbers: |
ALMED-09-C3-026 |
First Posted: | February 11, 2011 Key Record Dates |
Results First Posted: | December 21, 2015 |
Last Update Posted: | December 21, 2015 |
Last Verified: | December 2015 |
Xenon Sevoflurane Propofol Total intravenous anaesthesia |
Anaesthesia Coronary artery disease Coronary artery bypass graft |
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 Propofol Sevoflurane Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics Platelet Aggregation Inhibitors Anesthetics, Inhalation |