General anesthesia for on pump coronary artery bypass surgery MedDRA version: 14.1 Level: LLT Classification code 10006894 Term: CABG System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: LENOXe
Product Name: xenon
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Xenon
CAS Number: 007440-63-3
Current Sponsor code: Xenon
Other descriptive name: LENOXe
Concentration u
Sponsors
Air Liquide Santé International
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Male or female patients aged 18 years (or having reached majority if the legal age of majority is over 18) or more at the date of selection 2)Coronary heart disease requiring elective isolated coronary artery bypass graft surgery to be performed with cardiopulmonary bypass in mild hypothermia (central temperature between 32° and 34° Celsius) or normothermia with cardiac arrest and cold or warm cardioplegia 3)Normal or moderately impaired left ventricular systolic function (corresponding to a left ventricular ejection fraction above or equal to 35%, if available) 4)Written informed consent signed and dated by the patient after full explanation of the study has been given by the investigator prior to participation Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 412 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 96
Exclusion criteria
Exclusion criteria: -Legal incapacity or limited legal capacity - Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods - Patient previously randomised in this study - Recent acute myocardial infarction (within 7 days) - Ongoing unstable angina - Active endocarditis - Ongoing treatment with nicorandil - Ongoing treatment with a sulfonylurea medication if this treatment cannot be replaced 24 hours before surgery - Participation in a drug or device trial within the previous 30 days - Known contraindication to xenon, sevoflurane, propofol or sufentanil - Recent or ongoing myocardial damage/infraction with cardiac troponin level assessed within 24 hours of surgery above the upper reference limite for the diagnosis of mycocardial infraction (local laboratory) or prolonged thoracic pain and ST-segement deviation at rest - Severe renal dysfunction with preoperative value of serum creatinine level above 200 micromoles/litre(local laboratory) - Severe haptic dysfunction with preoperative value of alanine amine-transferase or alkaline phosphatase three times above the upper normal value(loval laboratory) - Severely depressed left ventricular function, corresponding to an ejection fraction below 35%,if available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of xenon anesthesia on the posteoperative blood level of cardiac troponin, a predictive marker of medium and long term clinical outcome after coronary artery bypass graft surgery 24 hours after the end of intervention, compared to sevoflurane anesthesia and total intravenous anesthesia.;Secondary Objective: - To assess the effect of xenon on other myocardial damage-related criteria and on short term consequences of myocardial damage - To assess the feasbility of xenon for cornoary artery bypass graft surgery - To assess the effect of xenon of the postoperative follow-up, during intensive care unit stay and hospital saty - To assess the effect of xenon on the incidence of posteperative delirium -To assess the effect of xenon on safety ;Primary end point(s): Cardiac troponin blood level measured 24 hours after the end of intervention (central laboratory);Timepoint(s) of evaluation of this end point: This time point is the most frequently chosen time point reported in studies performed to investigate the correlation between troponin levels and clinical outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: From the inclusion to the hospital discharge. During anaesthesia, 12 hours, 24hours, 48 hours, at the ICU discharge, at the hospital discharge. For CAM test, at inclusion then once a day as soon as trachea is extubated, at the ICU discharge and Hospital discharge ;Secondary end point(s): Other myocardial damage ( blood cardiac troponin, CK-MB levels, MI type 5 , NT-proBNP levels, CRP levels),feasibility of xenon as anaesthetic during CABG, ICU parameters(blood loss, blood transfusion, length of stay) mechamical ventilation , incidence on post operative delirium (CAM test), safety (Adverse event) | — |
Countries
Germany, Netherlands
Contacts
Public ContactAmit Singla
ORION Clinical Services Limited
Outcome results
None listed