drugset / Trial / NCT01120405
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Phase 3
Completed
600 enrolled
Air Liquide
Eurofins Biomnis · collabInferential · collabMonitoring Force Group · collab
RandomizedParallel-groupSingle-blindScreening
Summary
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
Timeline
- Start
- 2010-05
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sevoflurane | Other / unclassified | — | — |
| Subject | Xenon | Other / unclassified | — | — |