general anaesthesia.
Conditions
Interventions
Trade Name: LENOXe 100% (V/V)
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Xenon
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number: 100-
Pha
Sponsors
AIR LIQUIDE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient from 50 to 75 years old (both included) ASA (American Society of Anaesthesiologists) physical status III Patient with coronary heart disease, stable during the last 6 months prior to selection Surgical operation: laparotomy Planned duration of general anaesthesia in the range of 2 -6 hours Patient willing and able to complete the requirements of this study including the signature of the written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient with severe impairment of cardiac function (Left Ventricular Ejection Fraction < 35% evaluated within 12 months prior to selection) Patient with drug-eluding stent Woman of child-bearing potential not implementing adequate contraceptive methods Pregnant or lactating woman Surgical procedure in emergency Chronic therapy with opioids for pain relief Serious illness or medical conditions which are possible contra indication for elective general anaesthesia or administration of intra operative treatments, or which are interfering with the monitoring devices, such as: -Myocardial infarction within 6 months prior to selection -Any significant history of allergic disease/hypersensitivity or allergy/hypersensitivity to any drugs used during the study, to silicone or to latex -Severely impaired hearing -Any medical condition which does not justify the trial participation in the investigator’s judgement -General anaesthesia within 7 days prior to selection -Laparotomy within 12 months prior to selection History of drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally not able to give written informed consent Concurrent treatment with any other experimental drugs Participation in any other clinical trial within 4 weeks prior to selection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate, during the maintenance period of general anaesthesia at comparable depths, the quantity of propofol (mg) administered (adjusted to the patient body surface area and the anaesthesia maintenance duration) with Xenon in inspiratory concentrations of 50% (45%-55%) and 70% (65%-75%), delivered by a Felix Dual® ventilator, versus total i.v. anaesthesia in ASA III patients presenting stable coronary heart disease and undergoing laparotomy;Secondary Objective: To assess recovery parameters To collect safety data, including haemodynamic, respiratory and laboratory parameters ;Primary end point(s): Quantity of propofol (mg) administered during the anaesthesia maintenance adjusted to the patient body surface area and the anaesthesia maintenance duration | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed