Status:
TERMINATED
General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
Lead Sponsor:
Air Liquide SA
Conditions:
Anaesthesia
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the quantity of propofol administered with Xenon in two inspiratory concentrations, to maintain comparable depth of anaesthesia during the maintenance period o...
Detailed Description
The inert or "noble" gas Xenon has anaesthetic properties that have been recognized 50 years ago. Several preclinical studies and investigations using xenon as an inhalational anaesthetic in humans we...
Eligibility Criteria
Inclusion
- Patient ≥ 50 years old
- ASA (American Society of Anaesthesiologists) Physical Status III
- Patient with increased risk of perioperative cardiac complications (Revised Cardiac Risk Index\>=2)
- Surgical operation: laparotomy or orthopaedic surgery or laparoscopy
- 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
Exclusion
- Patient with severe impairment of cardiac function (Left Ventricular Ejection Fraction \< 35%)
- Patient with drug-eluting 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 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00919126
Start Date
June 1 2009
End Date
January 1 2012
Last Update
September 25 2014
Active Locations (6)
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1
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63058
2
Groupe Hospitalier Universitaire Caremeau
Nîmes, France, 30029
3
Evangelisches Waldkrankenhaus Berlin-Spandau
Berlin, Germany, D-14129
4
BG Kliniken-Bergmannstrost
Halle, Germany, D-06112