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

Anaesthesia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00919126
• Other study ID #: ALMED-07-C3-007
• Secondary ID: 2007-001979-10
• Status: Terminated
• Phase: Phase 3
• First received: June 11, 2009
• Last updated: September 15, 2014
• Start date: June 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2014
• Source: Air Liquide SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaesthesia

Intervention

Drug:
• Xenon
Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
• Xenon
Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
• Medical Air in Oxygen
Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-Ferrand
France	Groupe Hospitalier Universitaire Caremeau	Nîmes
Germany	Evangelisches Waldkrankenhaus Berlin-Spandau	Berlin
Germany	BG Kliniken-Bergmannstrost	Halle
Germany	University Hospital Schleswig-Holstein	Kiel
United Kingdom	Manchester Royal Infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide SA

Countries where clinical trial is conducted

France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Anaesthesia Recovery Time	Time interval between the end of maintenance period and time of tracheal tube removal.	1 Postoperative Day	Yes
Secondary	Awakening Time	Time interval between the end of maintenance period and time of Aldrete score = 9.	1 Postoperative Day	Yes
Secondary	Stay in the Operating Room	Time interval between admission in the operating room and discharge from the operating room.	1 Postoperative Day	Yes
Secondary	Stay in the Recovery Room	Time interval between admission in the recovery room and discharge from the recovery room.	1 Postoperative Day	Yes
Secondary	Haematology - Leucocytes (Giga/L)	Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.	1 Postoperative Day	Yes
Secondary	Haematology - Erythrocytes (Tera/L)	Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.	1 Postoperative Day.	Yes
Secondary	Haematology - Platelets (Giga/L)	Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery	1 Postoperative Day	Yes
Secondary	Serum Chemistry - AST (GOT) (IU/L)	AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.	1 Postoperative Day	Yes
Secondary	Serum Chemistry - ALT (GPT) (IU/L)	ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery	1 Postoperative Day	Yes
Secondary	Serum Chemistry - Gamma GT (IU/L)	Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery	1 Postoperative Day	Yes
Secondary	Serum Chemistry - Creatinine (Mcmol/L)	Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery	1 Postoperative Day	Yes
Secondary	Serum Chemistry - Urea (mmol/L)	Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery	1 Postoperative Day	Yes