AN INTERNATIONAL PHASE III RANDOMISED TRIAL COMPARING THE PROPOFOL CONSUMPTION DURING GENERAL ANAESTHESIA WITH XENON IN INSPIRATORY CONCENTRATIONS OF 50 % AND 70% AND TOTAL IV ANAESTHESIA ALONE IN ASA III PATIENTS WITH STABLE CORONARY HEART DISEASE - General anaesthesia with xeno

Phase 1

• Conditions: general anaesthesia.

• Registration Number: EUCTR2007-001979-10-FR
• Lead Sponsor: AIR LIQUIDE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-17
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To collect safety data, including haemodynamic, respiratory and laboratory parameters<br>;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