Trial · NCT01294163
Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
NCT01294163, Phase 3, Completed, Air Liquide Santé International; results first posted 2015-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery. Trials, record NCT01294163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01294163
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Xenon Compared to Sevoflurane and Total Intravenous Anaesthesia for Coronary Artery Bypass Graft Surgery
- NCT number
- NCT01294163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 509 participants, actual
- Lead sponsor
- Air Liquide Santé International
- Conditions
- Coronary Artery Disease, General Anesthetic Drug Allergy, Coronary Artery Bypass Graft Surgery
- Interventions
- Xenon, Sevoflurane, Propofol
- First posted
- 2011-02-11
- Last updated
- 2026-07-22
- Results first posted
- 2015-12-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood Level of Troponin I | Sampling performed 24 hours after the end of the surgical procedure | Blood level of troponin I measured by a central laboratory |
| Primary | Log-transformed Blood Level of Troponin I | Sampling performed 24 hours after the end of the surgical procedure | Blood level of troponin I measured by a central laboratory |
| Secondary | Depth of Anaesthesia | 4 hours | On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor) |
| Secondary | Arterial Oxygen Saturation | 4 hours | Arterial blood gases |
| Secondary | Haemodynamic Profile | 4 hours | Monitoring of heart rate, arterial blood pressure, central venous pressure. |
| Secondary | Presence or Absence of Postoperative Delirium | 7 days | Confusion Assessment Method |
| Secondary | Clinical Laboratory Tests | 7 days | |
| Secondary | ECG Abnormalities | 7 days | |
| Secondary | Vital Signs | 7 days | |
| Secondary | Presence of Absence of Adverse Events, Including Myocardial Infarction | 7 days |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Blood Level of Troponin I | Sampling performed 24 hours after the end of the surgical procedure | The primary analysis was a non-inferiority comparison between Xenon and Sevoflurane and was performed on the Per Protocol (PP) Set composed of all randomised and treated patients with no major protocol deviations during the study. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Depth of Anaesthesia | 4 hours | |||
| SECONDARY | Arterial Oxygen Saturation | 4 hours | |||
| SECONDARY | Haemodynamic Profile | 4 hours | |||
| SECONDARY | Presence or Absence of Postoperative Delirium | 7 days | |||
| SECONDARY | Clinical Laboratory Tests | 7 days | |||
| SECONDARY | ECG Abnormalities | 7 days | |||
| SECONDARY | Vital Signs | 7 days | |||
| SECONDARY | Presence of Absence of Adverse Events, Including Myocardial Infarction | 7 days | |||
| PRIMARY | Log-transformed Blood Level of Troponin I | Sampling performed 24 hours after the end of the surgical procedure | The non-inferiority comparison between Xenon and Sevoflurane was repeated using log-transformed blood troponin levels on the PP Set. | ng/mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Blood Level of Troponin I | Xenon | 2.16 | 95% Confidence Interval 1.54 to 2.78 | ng/mL | |
| Blood Level of Troponin I | Sevoflurane | 2.57 | 95% Confidence Interval 1.96 to 3.18 | ng/mL | |
| Log-transformed Blood Level of Troponin I | Xenon | 0.30 | 95% Confidence Interval 0.15 to 0.44 | ng/mL | |
| Log-transformed Blood Level of Troponin I | Sevoflurane | 0.39 | 95% Confidence Interval 0.25 to 0.54 | ng/mL |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Xenon Including Pilot Patients | 178 | |
| Overall Study | STARTED | Sevoflurane | 165 | |
| Overall Study | STARTED | TIVA | 166 | |
| Overall Study | COMPLETED | Xenon Including Pilot Patients | 177 | |
| Overall Study | COMPLETED | Sevoflurane | 165 | |
| Overall Study | COMPLETED | TIVA | 163 | |
| Overall Study | NOT COMPLETED | Xenon Including Pilot Patients | 1 | |
| Overall Study | NOT COMPLETED | Sevoflurane | 0 | |
| Overall Study | NOT COMPLETED | TIVA | 3 |
Source ClinicalTrials.gov
Adverse events297
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial fibrillation | Cardiac disorders | Xenon Including Pilot Patients | 55 | 178 | |
| other | Atrial fibrillation | Cardiac disorders | Sevoflurane | 43 | 165 | |
| other | Atrial fibrillation | Cardiac disorders | TIVA | 37 | 166 | |
| other | Tachycardia | Cardiac disorders | Xenon Including Pilot Patients | 14 | 178 | |
| other | Tachycardia | Cardiac disorders | Sevoflurane | 7 | 165 | |
| other | Tachycardia | Cardiac disorders | TIVA | 14 | 166 | |
| other | Bradycardia | Cardiac disorders | Xenon Including Pilot Patients | 12 | 178 | |
| other | Bradycardia | Cardiac disorders | Sevoflurane | 9 | 165 | |
| other | Bradycardia | Cardiac disorders | TIVA | 13 | 166 | |
| other | Pericardial effusion | Cardiac disorders | Xenon Including Pilot Patients | 9 | 178 |
1 to 10 of 297Source ClinicalTrials.gov
See all 297 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Xenon Including Pilot Patients | ||
| Total, all-cause mortality | Sevoflurane | ||
| Total, all-cause mortality | TIVA | ||
| Total, other adverse events | Xenon Including Pilot Patients | 154 | 178 |
| Total, other adverse events | Sevoflurane | 139 | 165 |
| Total, other adverse events | TIVA | 143 | 166 |
| Total, serious adverse events | Xenon Including Pilot Patients | 30 | 178 |
| Total, serious adverse events | Sevoflurane | 24 | 165 |
| Total, serious adverse events | TIVA | 26 | 166 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01294163
GET https://conductscience.org/api/trials/v1/NCT01294163/events?page=2