General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.

This study has been terminated.
(Enrollment rate)
Information provided by (Responsible Party):
Air Liquide SA Identifier:
First received: June 11, 2009
Last updated: February 2, 2012
Last verified: February 2012

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 of general anaesthesia.

Condition Intervention Phase
Drug: Xenon
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: An International Phase III Randomised Trial Comparing the Propofol Consumption During General Anaesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia Alone in ASA III Patients With Increased Risk of Perioperative Cardiac Complications.

Further study details as provided by Air Liquide SA:

Primary Outcome Measures:
  • Quantity of propofol administered during the anaesthesia maintenance [ Time Frame: 2 - 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery parameters, laboratory parameters. [ Time Frame: 1 - 10 days ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: June 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Xenon 50% (45%-55%) in Oxygen (FiO2 0.45-0.55),
Drug: Xenon
Randomised patients will undergo surgical procedure with general anaesthesia maintained by remifentanil and propofol, in association with:
Experimental: Group B
Xenon 70%(65%-75%) in Oxygen (FiO2 0.25-0.35)
Drug: Xenon
Randomised patients will undergo surgical procedure with general anaesthesia maintained by remifentanil and propofol, in association with:
Active Comparator: Group C
Medical Air in Oxygen(FiO2 0.45-0.55)
Drug: Xenon
Randomised patients will undergo surgical procedure with general anaesthesia maintained by remifentanil and propofol, in association with:

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 were performed and reported that this gas has many properties of the ideal anaesthetic agent. Moreover, it is known that when xenon is combined with volatile anaesthetics or opioids, the required doses of those substances are reduced, resulting in a lower incidence of side effects. Patients could benefit from the administration of xenon if this inspired concentration would result in reduced doses of co-administered drugs.

This trial should allow evaluating the propofol consumption required in combination with xenon administered in inspiratory concentrations of 50% and 70% to maintain comparable depth of general anaesthesia as total i.v. anaesthesia, in ASA III patients presenting increased risk of perioperative cardiac complications and undergoing laparotomy or orthopaedic surgery.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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 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 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00919126

Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63058
Groupe Hospitalier Universitaire Caremeau
Nîmes, France, 30029
Evangelisches Waldkrankenhaus Berlin-Spandau
Berlin, Germany, D-14129
BG Kliniken-Bergmannstrost
Halle, Germany, D-06112
University Hospital Schleswig-Holstein
Kiel, Germany, D-24105
United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M139WL
Sponsors and Collaborators
Air Liquide SA
Principal Investigator: Berthold BEIN, Prof Dr Med University of Schleswig-Holstein
Study Chair: Jens SCHOLZ, Prof. Dr Med University of Schleswig-Holstein
  More Information

No publications provided

Responsible Party: Air Liquide SA Identifier: NCT00919126     History of Changes
Other Study ID Numbers: ALMED-07-C3-007, 2007-001979-10
Study First Received: June 11, 2009
Last Updated: February 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Air Liquide SA:
Xenon in Anaesthesia

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General processed this record on April 21, 2014