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

NCT ID: NCT01120405

Last Updated: 2014-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Xenon

0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)

Group Type: EXPERIMENTAL

Xenon

Intervention Type: DRUG

sevoflurane

0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

Interventions

Xenon

Intervention Type: DRUG

Sevoflurane

Intervention Type: DRUG

Other Intervention Names

LENOXe; Sevo

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,
• Cardiac ischaemic risk supported by:

• History of myocardial infarction older than 1 month and/or
• Documented Stable angina (asymptomatic ± medical treatment) and/or
• History of coronary revascularisation, and/or
• Surgical Risk Index ("Lee" index) ≥ 3.
• Written informed consent

Exclusion Criteria

• Unstable angina within the last 30 days,
• Non controlled arterial Hypertension .
• Severe Cardiac heart Failure (NYHA IV)
• Severe Chronic Obstructive Pulmonary Disease
• Patient already randomized in another ongoing clinical trial
• Patient with recent myocardial infarction (M.I) (less than one month )
• Patient already included in a clinical trial
• History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane, desflurane, isoflurane)
• Malignant hyperthermia
• Documented Elevated intracranial pressure
• Preeclampsia or eclampsia
• Pregnancy and lactation
• Presumed uncooperativeness or legal incapacity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Biomnis

OTHER

Sponsor Role: collaborator

Monitoring Force Group

INDUSTRY

Sponsor Role: collaborator

Inferential

INDUSTRY

Sponsor Role: collaborator

Air Liquide Santé International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanncik Le Manach, MD

Role: PRINCIPAL_INVESTIGATOR

CHU PITIE SALPETRIERE, PARIS, FRANCE

Pierre CORIAT, MD Prof

Role: STUDY_CHAIR

CHU PITIE SALPETRIERE, PARIS, FRANCE

Benoit VALLET, MD Prof

Role: STUDY_CHAIR

University Hospital, Lille

Locations

Nouvel Hopital Civil

Strasbourg, Bas Rhin, France

CHU Nord

Marseille, Bouches du Rhône, France

Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre

Caen, Calvados, France

CHU Dijon

Dijon, Côte d'Or, France

Hopital Pellegrin

Bordeaux, Gironde, France

CHU Bordeaux Haut Lévèque

Bordeaux, Gironde, France

CHU Rennes

Rennes, Ille et Vilaine, France

CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc

Lille, Nord, France

Chu Pitie Salpetriere

Paris, Paris, France

Hopital Saint Joseph

Paris, Paris, France

CHU Clermont Ferrand

Clermont-Ferrand, Puy de Dôme, France

Hopital Henri Mondor

Créteil, Val de Marne, France

CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577

Poitiers, Vienne, France

Countries

France

Other Identifiers

EudraCT #2010-018703-28

Identifier Type: -

Identifier Source: org_study_id