NCT01120405

Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery

Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The Primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac Troponin I (cTnI) at any time during the 72 h post operatively. Time frame 3 days post-op; Key secondary endpoint(s) are routine (Local laboratory) dosage of standard cardiac Troponin I (cTnI) at D1 (24h) and D3 (72 h) post operatively, and also in case of any suspicion of Myocardial Infarction , Routine cardiac safety monitoring.

Conditions

• Elevated Cardiac Risk
• Coronary Arteries Disease Risk

Interventions

Type	Name	Description
DRUG	Xenon
DRUG	Sevoflurane

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-05-11
• Last updated: 2014-06-17
• Results posted: 2014-06-17

Locations

13 sites across 1 country: France