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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Screening
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2012

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.

Interventions

  • Drug: Xenon
  • Drug: Sevoflurane

Arms, Groups and Cohorts

  • Experimental: Xenon
    • 0.8-1.1 minimum alveolar concentration (MAC) Xenon in 30 % oxygen (Group A)
  • Active Comparator: sevoflurane
    • 0.8-1.1 Minimum Alveolar Concentration (MAC) Sevoflurane in 30 % oxygen (Group B)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Myocardial Necrosis (MN)
    • Time Frame: 3 Postoperative Days
    • Myocardial Necrosis: at least 1 value of serum cardiac troponin I above the 99th percentile (measurement performed by a central laboratory using the ABBOTT-ARCHITECT technique)

Secondary Measures

  • Number of Participants With Cardiac Troponin I or T Above the 99th Percentile (Local Laboratories)
    • Time Frame: 3 Postoperative days
    • At least 1 value of serum cardiac troponin I or T above the 99th percentile (measurements performed by local laboratories using different techniques)
  • Number of Participants With Myocardial Infarction (MI)
    • Time Frame: 3 Postoperative Days
    • Patients with Confirmed Myocardial Infarction (MI) by the Investigators
  • Number of Participants With Cerebro-Vascular Event
    • Time Frame: 3 postoperative days
    • Patients with Cerebro-Vascular Event in the FAS
  • Number of Participants With Life-Threatening Arrhythmia
    • Time Frame: 3 Postoperative Days
    • Patients with Life-Threatening Arrhythmia in the FAS
  • Number of Participants Who Died From Cardiac Origin
    • Time Frame: 3 postoperative days
    • No patient died from a cardiac cause during the 3 postoperative days.
  • Number of Participants With Composite Endpoint
    • Time Frame: 3 postoperative days
    • Patients with at least 1 event among MN assessed by central laboratory, MI, Cerebro-Vascular event, Life-Threatening Arrhythmia and Death from Cardiac Origin
  • Systolic Blood Pressure (SBP)
    • Time Frame: From pre-induction to recovery of anesthesia
    • Repeated Systolic Blood Pressure measurements during the perioperative period
  • Vital Signs (SBP and DBP Changes)
    • Time Frame: From pre-induction to Postoperative Day 3
    • Changes from baseline for Systolic and Diastolic Blood Pressure (SBP and DBP)
  • Vital Signs (Heart Rate Changes)
    • Time Frame: From pre-induction to Postoperative Day 3
    • Changes from baseline for Heart Rate (HR)
  • Number of Participants With Chest Pain During the 3 Postoperative Days
    • Time Frame: From Day 0 until Postoperative Day 3
    • Patients with Chest Pain reported at least once per day during the 3 Postoperative Days
  • Urine Output
    • Time Frame: From Day 0 until Postoperative Day 1
    • Urine volume in milliliter (mL) during the first postoperative hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Liquide Santé International
  • Collaborator
    • Eurofins Biomnis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yanncik Le Manach, MD, Principal Investigator, CHU PITIE SALPETRIERE, PARIS, FRANCE
    • Pierre CORIAT, MD Prof, Study Chair, CHU PITIE SALPETRIERE, PARIS, FRANCE
    • Benoit VALLET, MD Prof, Study Chair, University Hospital, Lille

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