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

NCT01120405 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2014-06-17

Study results available
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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.

Conditions

  • Elevated Cardiac Risk
  • Coronary Arteries Disease Risk

Interventions

DRUG

Xenon

DRUG

Sevoflurane

Sponsors & Collaborators

  • Eurofins Biomnis

    collaborator OTHER

  • Monitoring Force Group

    collaborator INDUSTRY

  • Inferential

    collaborator INDUSTRY

  • Air Liquide Santé International

    lead INDUSTRY

Principal Investigators

  • Yanncik Le Manach, MD · CHU PITIE SALPETRIERE, PARIS, FRANCE

  • Pierre CORIAT, MD Prof · CHU PITIE SALPETRIERE, PARIS, FRANCE

  • Benoit VALLET, MD Prof · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120405 on ClinicalTrials.gov