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

This study has been terminated.
(Enrollment rate)
Sponsor:
Information provided by (Responsible Party):
Air Liquide SA
ClinicalTrials.gov Identifier:
NCT00919126
First received: June 11, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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
Anaesthesia
Drug: Xenon
Drug: Medical Air in Oxygen
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.

Resource links provided by NLM:


Further study details as provided by Air Liquide SA:

Primary Outcome Measures:
  • Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min) [ Time Frame: Maintenance period (1 Day) ] [ Designated as safety issue: No ]
    Dose of propofol administered with a Target Controlled Infusion (TCI) device, cerebral concentration equal to 5 µg/mL at the end of induction, and then concentration adjusted to the level of depth of anaesthesia during maintenance. Depth of anaesthesia continuously assessed by signals derived from electroencephalographic recording. Analgesia during induction and maintenance obtained with remifentanil administered with a second TCI device at the stable cerebral concentration of 7 ng/mL.


Secondary Outcome Measures:
  • Anaesthesia Recovery Time [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Time interval between the end of maintenance period and time of tracheal tube removal.

  • Awakening Time [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Time interval between the end of maintenance period and time of Aldrete score ≥ 9.

  • Stay in the Operating Room [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Time interval between admission in the operating room and discharge from the operating room.

  • Stay in the Recovery Room [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Time interval between admission in the recovery room and discharge from the recovery room.

  • Haematology - Leucocytes (Giga/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.

  • Haematology - Erythrocytes (Tera/L) [ Time Frame: 1 Postoperative Day. ] [ Designated as safety issue: Yes ]
    Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.

  • Haematology - Platelets (Giga/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery

  • Serum Chemistry - AST (GOT) (IU/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.

  • Serum Chemistry - ALT (GPT) (IU/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery

  • Serum Chemistry - Gamma GT (IU/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery

  • Serum Chemistry - Creatinine (Mcmol/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery

  • Serum Chemistry - Urea (mmol/L) [ Time Frame: 1 Postoperative Day ] [ Designated as safety issue: Yes ]
    Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery


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 (45%-55%),
Drug: Xenon
Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
Other Name: Xenon
Experimental: Group B
Xenon 70% (65%-75%) in Oxygen (25%-35%)
Drug: Xenon
Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
Other Name: Xenon
Active Comparator: Group C
Medical Air in Oxygen (45%-55%)
Drug: Medical Air in Oxygen
Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
Other Name: Medical Air in Oxygen

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.

  Eligibility

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

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919126

Locations
France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France, 63058
Groupe Hospitalier Universitaire Caremeau
Nîmes, France, 30029
Germany
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
Investigators
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
ClinicalTrials.gov Identifier: NCT00919126     History of Changes
Other Study ID Numbers: ALMED-07-C3-007, 2007-001979-10
Study First Received: June 11, 2009
Results First Received: June 4, 2014
Last Updated: June 18, 2014
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
Anesthetics
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on July 22, 2014