Xenon
DrugOther names: LENOXe
Completed
NCT Number: NCT01120405
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Nouvel Hopital Civil, Strasbourg, Bas Rhin, France
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sevoflurane
DrugOther names: Sevo
Primary outcomes
-
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 outcomes
-
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
Sponsors and collaborators
Lead sponsor
Air Liquide Santé International
Industry
Collaborators
- Eurofins Biomnis
- Inferential
- Monitoring Force Group
Registry information
Official study title
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery: A Phase III Multicenter Randomized Controlled Study
Acronym: CARVASAXe
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- May 11, 2010
- Registry last updated
- Jun 17, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.