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

Phase 3

Terminated

• Conditions: Anaesthesia
• Interventions: Drug: Xenon; Drug: Medical Air in Oxygen

• Registration Number: NCT00919126
• Lead Sponsor: Air Liquide SA

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Results First Submitted: 2014-06-04
• Results First Submitted QC: 2014-06-18
• Results First Posted: 2014-07-17
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Xenon	Xenon 70% (65%-75%) in Oxygen (25%-35%)
Group C	Medical Air in Oxygen	Medical Air in Oxygen (45%-55%)
Group A	Xenon	Xenon 50% (45%-55%) in Oxygen (45%-55%),

Primary Outcome Measures

Name	Time	Method
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)	Maintenance period (1 Day)	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

Name	Time	Method
Haematology - Erythrocytes (Tera/L)	1 Postoperative Day.	Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.
Stay in the Recovery Room	1 Postoperative Day	Time interval between admission in the recovery room and discharge from the recovery room.
Anaesthesia Recovery Time	1 Postoperative Day	Time interval between the end of maintenance period and time of tracheal tube removal.
Serum Chemistry - ALT (GPT) (IU/L)	1 Postoperative Day	ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Serum Chemistry - Gamma GT (IU/L)	1 Postoperative Day	Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Awakening Time	1 Postoperative Day	Time interval between the end of maintenance period and time of Aldrete score ≥ 9.
Stay in the Operating Room	1 Postoperative Day	Time interval between admission in the operating room and discharge from the operating room.
Haematology - Leucocytes (Giga/L)	1 Postoperative Day	Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.
Serum Chemistry - AST (GOT) (IU/L)	1 Postoperative Day	AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.
Serum Chemistry - Creatinine (Mcmol/L)	1 Postoperative Day	Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Haematology - Platelets (Giga/L)	1 Postoperative Day	Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery
Serum Chemistry - Urea (mmol/L)	1 Postoperative Day	Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery

Trial Locations

Locations (6)

Groupe Hospitalier Universitaire Caremeau; 🇫🇷 Nîmes, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Evangelisches Waldkrankenhaus Berlin-Spandau; 🇩🇪 Berlin, Germany

BG Kliniken-Bergmannstrost; 🇩🇪 Halle, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom