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 INCREASED RISK OF PERIOPERATIVE CARDIAC COMPLICATIONS - General anaesthesia with xeno

Phase 1

• Conditions: general anaesthesia.

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-04-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

Patient = 50 years old
ASA (American Society of Anaesthesiologists) Status III
Patient with increased risk of perioperative cardiac complications
(Revised Cardiac Risk Index)
Surgical operation: laparotomy or laparoscopy or orthopaedic surgery
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%)
Patient with drug-eluding stent placed within 12 months prior to
selection
Woman of child-bearing potential not implementing adequate
contraceptive methods
Pregnant or lactating woman
Surgical procedure in emergency
Chronic opioids pain therapy
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 allergy/hypersensitivity to any drugs used
during the study, to silicone or to latex
- Severely impaired hearing
- Known severe neurological disorders
- 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 3 months prior to selection, only for patients
undergoing laparotomy
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 increased risk of perioperative cardiac complications and undergoing laparotomy, laparoscopy or orthopaedic surgery.;<br> 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