Efficacy and safety of xenon anaesthesia compared to sevoflurane anaesthesia and total intravenous anaesthesia for on-pump coronary artery bypass graft surgery: a randomised, three-arm, single-blind, international study.

• Register: EUCTR
• Last refreshed on: 23 November 2015
• Main ID: EUCTR2010-020677-17-DE
• Date of registration: 29/06/2011
• Prospective Registration: Yes
• Primary sponsor: Air Liquide Santé International
• Public title: Efficacy and safety of xenon anaesthesia compared to sevoflurane anaesthesia and total intravenous anaesthesia for on-pump coronary artery bypass graft surgery: a randomised, three-arm, single-blind, international study.
• Scientific title: Efficacy and safety of xenon anaesthesia compared to sevoflurane anaesthesia and total intravenous anaesthesia for on-pump coronary artery bypass graft surgery: a randomised, three-arm, single-blind, international study. - Xenon in Cardiac Surgery
• Date of first enrolment: 20/10/2011
• Target sample size: 509
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020677-17
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Sevoflurane(PR2),Propofol(PR3) Number of treatment arms in the trial: 3

Countries of recruitment

Germany, Netherlands

Contacts

• Name: Vice President Medical
• Affiliation: Air Liquide Santé International

• Name: Vice President Medical
• Affiliation: Air Liquide Santé International

Key inclusion & exclusion 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:
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:
-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 aminetransferase
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

General anesthesia for on pump coronary artery bypass surgery
MedDRA version: 16.0 Level: LLT Classification code 10006894 Term: CABG System Organ Class: 100000004865

Intervention(s)

Trade Name: LENOXe
Product Name: Xenon
Pharmaceutical Form: Medicinal gas, liquefied
CAS Number: 007440-63-3
Other descriptive name: XENON
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number: 100-

Product Name: Sevoflurane
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SEVOFLURANE
CAS Number: 28523-86-6
Other descriptive name: SEVOFLURANE
Concentration unit: % percent
Concentration type: equal
Concentration number: 1.8-

Product Name: Propofol
Pharmaceutical Form: Emulsion for injection
CAS Number: 2078-54-8
Other descriptive name: PROPOFOL
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: range
Concentration number: 2-4-

Primary Outcome(s)

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

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.

Primary end point(s): Cardiac troponin blood level measured 24 hours after the end of
intervention (central laboratory)

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 Outcome(s)

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)

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 ID(s)

ALMED-09-C3-026

2010-020677-17-NL

Source(s) of Monetary Support

Air Liquide Santé International