Coronary Artery DiseasePhase 3NCT01294163
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
A Phase 3 study testing Xenon, Sevoflurane and Propofol in people with Coronary Artery Disease and General Anesthetic Drug Allergy, run by Air Liquide Santé International at 17 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
- What is being tested?
- Xenon, Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 509 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Apr 2011to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy or child bearing potential
- ongoing treatment with nicorandil or sulfonylurea medication
- severe renal or hepatic dysfunction
- ongoing myocardial infarction or unstable angina
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
France8 sites
Hôpital Cardiovasculaire et Pneumologique Louis Pradel
Bron, 69677
CHU de Caen
Caen, 14033
Hôpital G&R Laennec - Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Centre Hospitalo-Universitaire Pitié-Salpetrière
Paris, 75013
Hôpital du Haut-Lévêque
Pessac, 33600
Hôpital Pontchaillou
Rennes, 35033
Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67091
Centre Hospitalier de Rangueil
Toulouse, 31059
Germany6 sites
University Hospital Aachen
Aachen, 52074
Klinikum Links der Weser - Senator-Wessling-Str. 1
Bremen, 28277
University Hospital Frankfurt AM Main
Frankfurt, 60590
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
UniversitatsKlinikum Schleswig-Holstein
Lübeck, 23538
University Hospital ROSTOCK
Rostock, 18057
Netherlands2 sites
Academic Medical Center - University of Amsterdam
Amsterdam, 1100 DD
Thorax Center - Erasmus MC
Rotterdam, 3000 CA
About this study
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
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.
Read the detailed description
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).
- Conditions
- Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
- Being tested
- Xenon, Sevoflurane, Propofol
- Keywords
- Xenon, Sevoflurane, Propofol, Total intravenous anaesthesia, Anaesthesia, Coronary artery disease, Coronary artery bypass graft
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Inhaled xenon, maximal inspired concentration of 65%.
SevofluraneDrug
Inhaled sevoflurane, maximal inspired concentration of 1.8%.
PropofolDrug
Hourly dose of 2-4 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | Not described Receives: Drug: Xenon |
| Sevoflurane | Active comparator | Not described Receives: Drug: Sevoflurane |
| Total intravenous anaesthesia | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Measured: Sampling performed 24 hours after the end of the surgical procedure
Log-transformed Blood Level of Troponin I
Blood level of troponin I measured by a central laboratory
Measured: Sampling performed 24 hours after the end of the surgical procedure
Secondary outcomes (8)
Depth of Anaesthesia
On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)
Measured: 4 hours
Arterial Oxygen Saturation
Arterial blood gases
Measured: 4 hours
Haemodynamic Profile
Monitoring of heart rate, arterial blood pressure, central venous pressure.
Measured: 4 hours
Presence or Absence of Postoperative Delirium
Confusion Assessment Method
Measured: 7 days
Clinical Laboratory Tests
Measured: 7 days
ECG Abnormalities
Measured: 7 days
Vital Signs
Measured: 7 days
Presence of Absence of Adverse Events, Including Myocardial Infarction
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Sponsor
- Investigators
- Jan HOFLAND, MD, PhD, Principal investigator, Thorax Centre Erasmus MC, Rotterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294163
- Sponsor's protocol ID
- ALMED-09-C3-026
- Status last verified
- Jun 2026
- First submitted
- 9 Feb 2011
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01294163
- Acronym / sponsor ID
- ALMED-09-C3-026
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 21 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: Xenon |
| Sevoflurane | Active comparator | Drug: Sevoflurane |
| Total intravenous anaesthesia | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- pregnancy or child bearing potential
- ongoing treatment with nicorandil or sulfonylurea medication
- severe renal or hepatic dysfunction
- ongoing myocardial infarction or unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonInhaled xenon, maximal inspired concentration of 65%. | Drug | Xenon |
| SevofluraneInhaled sevoflurane, maximal inspired concentration of 1.8%. | Drug | Sevoflurane |
| PropofolHourly dose of 2-4 mg/kg | Drug | Total intravenous anaesthesia |
Primary outcome
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
8 secondary outcomes
Depth of Anaesthesia
Time frame: 4 hours
Arterial Oxygen Saturation
Time frame: 4 hours
Haemodynamic Profile
Time frame: 4 hours
Presence or Absence of Postoperative Delirium
Time frame: 7 days
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan HOFLAND, MD, PhD principal investigator
Thorax Centre Erasmus MC, Rotterdam, the Netherlands
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon, Sevoflurane and Propofol in people with Coronary Artery Disease and General Anesthetic Drug Allergy, run by Air Liquide Santé International at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Germany, Netherlands, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Level of Troponin I (time frame: Sampling performed 24 hours after the end of the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.