Back to resultsGeneral Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
Primary Purpose
Anaesthesia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xenon
Xenon
Medical Air in Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Anaesthesia focused on measuring Xenon in Anaesthesia
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
Sites / Locations
- Centre Hospitalier Universitaire de Clermont-Ferrand
- Groupe Hospitalier Universitaire Caremeau
- Evangelisches Waldkrankenhaus Berlin-Spandau
- BG Kliniken-Bergmannstrost
- University Hospital Schleswig-Holstein
- Manchester Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Xenon 50% (45%-55%) in Oxygen (45%-55%),
Xenon 70% (65%-75%) in Oxygen (25%-35%)
Medical Air in Oxygen (45%-55%)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Anaesthesia Recovery Time
Time interval between the end of maintenance period and time of tracheal tube removal.
Awakening Time
Time interval between the end of maintenance period and time of Aldrete score ≥ 9.
Stay in the Operating Room
Time interval between admission in the operating room and discharge from the operating room.
Stay in the Recovery Room
Time interval between admission in the recovery room and discharge from the recovery room.
Haematology - Leucocytes (Giga/L)
Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.
Haematology - Erythrocytes (Tera/L)
Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.
Haematology - Platelets (Giga/L)
Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery
Serum Chemistry - AST (GOT) (IU/L)
AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.
Serum Chemistry - ALT (GPT) (IU/L)
ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Serum Chemistry - Gamma GT (IU/L)
Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Serum Chemistry - Creatinine (Mcmol/L)
Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Serum Chemistry - Urea (mmol/L)
Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00919126
Brief Title
General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Enrollment rate
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Air Liquide SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaesthesia
Keywords
Xenon in Anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Xenon 50% (45%-55%) in Oxygen (45%-55%),
Arm Title
Group B
Arm Type
Experimental
Arm Description
Xenon 70% (65%-75%) in Oxygen (25%-35%)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Medical Air in Oxygen (45%-55%)
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Xenon
Intervention Description
Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
Intervention Type
Drug
Intervention Name(s)
Medical Air in Oxygen
Intervention Description
Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
Primary Outcome Measure Information:
Title
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)
Description
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.
Time Frame
Maintenance period (1 Day)
Secondary Outcome Measure Information:
Title
Anaesthesia Recovery Time
Description
Time interval between the end of maintenance period and time of tracheal tube removal.
Time Frame
1 Postoperative Day
Title
Awakening Time
Description
Time interval between the end of maintenance period and time of Aldrete score ≥ 9.
Time Frame
1 Postoperative Day
Title
Stay in the Operating Room
Description
Time interval between admission in the operating room and discharge from the operating room.
Time Frame
1 Postoperative Day
Title
Stay in the Recovery Room
Description
Time interval between admission in the recovery room and discharge from the recovery room.
Time Frame
1 Postoperative Day
Title
Haematology - Leucocytes (Giga/L)
Description
Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.
Time Frame
1 Postoperative Day
Title
Haematology - Erythrocytes (Tera/L)
Description
Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.
Time Frame
1 Postoperative Day.
Title
Haematology - Platelets (Giga/L)
Description
Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery
Time Frame
1 Postoperative Day
Title
Serum Chemistry - AST (GOT) (IU/L)
Description
AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.
Time Frame
1 Postoperative Day
Title
Serum Chemistry - ALT (GPT) (IU/L)
Description
ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Time Frame
1 Postoperative Day
Title
Serum Chemistry - Gamma GT (IU/L)
Description
Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Time Frame
1 Postoperative Day
Title
Serum Chemistry - Creatinine (Mcmol/L)
Description
Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Time Frame
1 Postoperative Day
Title
Serum Chemistry - Urea (mmol/L)
Description
Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Time Frame
1 Postoperative Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold BEIN, Prof Dr Med
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens SCHOLZ, Prof. Dr Med
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Groupe Hospitalier Universitaire Caremeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Evangelisches Waldkrankenhaus Berlin-Spandau
City
Berlin
ZIP/Postal Code
D-14129
Country
Germany
Facility Name
BG Kliniken-Bergmannstrost
City
Halle
ZIP/Postal Code
D-06112
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M139WL
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
We'll reach out to this number within 24 hrs