Clinical trial NCT01120405: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Official title: Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Elevated Cardiac Risk
Coronary Arteries Disease Risk
Keywords: Xenon
Cardiac safety
Cardiovascular risk
Non cardiac surgery
Atherosclerotic vascular surgery
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Eurofins Biomnis
name: Monitoring Force Group
name: Inferential
First posted: 2010-05-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Number of Participants With Myocardial Necrosis (MN)
timeFrame: 3 Postoperative Days
Secondary outcomes:
measure: Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
timeFrame: 3 Postoperative days
measure: Number of Participants With Myocardial Infarction (MI)
timeFrame: 3 Postoperative Days
measure: Number of Participants With Cerebro-Vascular Event
timeFrame: 3 postoperative days
measure: Number of Participants With Life-Threatening Arrhythmia
timeFrame: 3 Postoperative Days
measure: Number of Participants Who Died From Cardiac Origin
timeFrame: 3 postoperative days
measure: Number of Participants With Composite Endpoint
timeFrame: 3 postoperative days
measure: Systolic Blood Pressure (SBP)
timeFrame: From pre-induction to recovery of anesthesia
measure: Vital Signs (SBP and DBP Changes)
timeFrame: From pre-induction to Postoperative Day 3
measure: Vital Signs (Heart Rate Changes)
timeFrame: From pre-induction to Postoperative Day 3
measure: Number of Participants With Chest Pain During the 3 Postoperative Days
timeFrame: From Day 0 until Postoperative Day 3
measure: Urine Output
timeFrame: From Day 0 until Postoperative Day 1
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
state: Bas Rhin
city: Marseille
country: France
facility: CHU Nord
state: Bouches du Rhône
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Pôle Anesthésie-Réanimation-SAMU, Avenue de la Côte de Nacre
state: Calvados
city: Dijon
country: France
facility: CHU Dijon
state: Côte d'Or
city: Bordeaux
country: France
facility: Hopital Pellegrin
state: Gironde
city: Bordeaux
country: France
facility: CHU Bordeaux Haut Lévèque
state: Gironde
city: Rennes
country: France
facility: CHU Rennes
state: Ille et Vilaine
city: Lille
country: France
facility: CHRU, Hôpital Cardiologique, Département Anesthésie-Réanimation, Bld du Président Jules Leclerc
state: Nord
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
state: Puy de Dôme
city: Creteil
country: France
facility: Hopital Henri Mondor
state: Val de Marne
city: Poitiers
country: France
facility: CHU Poitiers, Service Anesthésie-Réanimation, 2 rue de Milétrie, BP577
state: Vienne
city: Paris
country: France
facility: Chu Pitie Salpetriere
city: Paris
country: France
facility: Hopital Saint Joseph
Study officials:
affiliation: CHU PITIE SALPETRIERE, PARIS, FRANCE
name: Yanncik Le Manach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU PITIE SALPETRIERE, PARIS, FRANCE
name: Pierre CORIAT, MD Prof
role: STUDY_CHAIR
affiliation: University Hospital, Lille
name: Benoit VALLET, MD Prof
role: STUDY_CHAIR
References: