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

NCT00919126 | Terminated Phase 3 Results

• 2 other identifiers: ALMED-07-C3-0072007-001979-10
• Study Type: interventional
• Target: 102
• Locations: 3 countries
• Sites: 6

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 of general anaesthesia.

Conditions

Anaesthesia

Keywords

Xenon in Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)

  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.

  Maintenance period (1 Day)

Secondary Outcomes (12)

• Anaesthesia Recovery Time

  1 Postoperative Day

• Awakening Time

  1 Postoperative Day

• Stay in the Operating Room

  1 Postoperative Day

• Stay in the Recovery Room

  1 Postoperative Day

• Haematology - Leucocytes (Giga/L)

  1 Postoperative Day

Study Arms (3)

Group A

EXPERIMENTAL

Xenon 50% (45%-55%) in Oxygen (45%-55%),

Drug: Xenon

Group B

EXPERIMENTAL

Xenon 70% (65%-75%) in Oxygen (25%-35%)

Drug: Xenon

Group C

ACTIVE COMPARATOR

Medical Air in Oxygen (45%-55%)

Drug: Medical Air in Oxygen

Interventions

Xenon DRUG

Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.

Group A

Medical Air in Oxygen DRUG

Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.

Group C

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Liquide SA: lead

Study Sites (6)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63058, France

Location

Groupe Hospitalier Universitaire Caremeau

Nîmes, 30029, France

Location

Evangelisches Waldkrankenhaus Berlin-Spandau

Berlin, D-14129, Germany

Location

BG Kliniken-Bergmannstrost

Halle, D-06112, Germany

Location

University Hospital Schleswig-Holstein

Kiel, D-24105, Germany

Location

Manchester Royal Infirmary

Manchester, M139WL, United Kingdom

Location

MeSH Terms

Interventions

Xenon; Air; Oxygen

Intervention Hierarchy (Ancestors)

Noble Gases; Elements; Inorganic Chemicals; Gases; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Chalcogens

Limitations and Caveats

The study has been terminated earlier due to difficulties to find patients meeting the inclusion criteria.

Results Point of Contact

• Title: Prof. Dr. Med Berthold BEIN
• Organization: University Hospital Schleswig-Holstein

bein@anasthesie.uni-kiel.de

+49(0)431-5973 739

Study Officials

• Berthold BEIN, Prof Dr Med

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

• Jens SCHOLZ, Prof. Dr Med

  University Hospital Schleswig-Holstein

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: September 25, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-09

Locations

FR (2); GB (1); DE (3)