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NCT Number: NCT01294163

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Bypass Graft Surgery Coronary Disease General Anesthetic Drug Allergy Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Bron, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xenon

Drug

Inhaled xenon, maximal inspired concentration of 65%.

Sevoflurane

Drug

Inhaled sevoflurane, maximal inspired concentration of 1.8%.

Propofol

Drug

Hourly dose of 2-4 mg/kg

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Depth of Anaesthesia

    Time frame: 4 hours

    On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)

  2. Arterial Oxygen Saturation

    Time frame: 4 hours

    Arterial blood gases

  3. Haemodynamic Profile

    Time frame: 4 hours

    Monitoring of heart rate, arterial blood pressure, central venous pressure.

  4. Presence or Absence of Postoperative Delirium

    Time frame: 7 days

    Confusion Assessment Method

  5. Clinical Laboratory Tests

    Time frame: 7 days

  6. ECG Abnormalities

    Time frame: 7 days

  7. Vital Signs

    Time frame: 7 days

  8. Presence of Absence of Adverse Events, Including Myocardial Infarction

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2011
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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