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

NCT ID: NCT00919126

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-01-31

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.

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.

Conditions

Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Xenon

Intervention Type: DRUG

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

Group B

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

Group Type: EXPERIMENTAL

Xenon

Intervention Type: DRUG

Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.

Group C

Medical Air in Oxygen (45%-55%)

Group Type: ACTIVE_COMPARATOR

Medical Air in Oxygen

Intervention Type: DRUG

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

Interventions

Xenon

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

Intervention Type: DRUG

Xenon

Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.

Intervention Type: DRUG

Medical Air in Oxygen

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Liquide SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Berthold BEIN, Prof Dr Med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Jens SCHOLZ, Prof. Dr Med

Role: STUDY_CHAIR

University Hospital Schleswig-Holstein

Locations

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Groupe Hospitalier Universitaire Caremeau

Nîmes, , France

Evangelisches Waldkrankenhaus Berlin-Spandau

Berlin, , Germany

BG Kliniken-Bergmannstrost

Halle, , Germany

University Hospital Schleswig-Holstein

Kiel, , Germany

Manchester Royal Infirmary

Manchester, , United Kingdom

Countries

France; Germany; United Kingdom

Other Identifiers

2007-001979-10

Identifier Type: -

Identifier Source: secondary_id

ALMED-07-C3-007

Identifier Type: -

Identifier Source: org_study_id