AnaesthesiaPhase 3NCT00919126
General Anesthesia With Xenon in Inspiratory Concentrations of 50% and 70% and Total I.V. Anaesthesia.
A Phase 3 study testing Xenon and Medical Air in Oxygen in people with Anaesthesia, run by Air Liquide SA at 6 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Anaesthesia
- What is being tested?
- Xenon and Medical Air in Oxygen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2009to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Evangelisches Waldkrankenhaus Berlin-Spandau
Berlin, D-14129
BG Kliniken-Bergmannstrost
Halle, D-06112
University Hospital Schleswig-Holstein
Kiel, D-24105
France2 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63058
Groupe Hospitalier Universitaire Caremeau
Nîmes, 30029
About this study
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.
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.
Read the 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
- Being tested
- Xenon, Medical Air in Oxygen
- Keywords
- Xenon in Anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Maintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia.
XenonDrug
Maintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia.
Medical Air in OxygenDrug
Maintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Xenon 50% (45%-55%) in Oxygen (45%-55%), Receives: Drug: Xenon |
| Group B | Experimental | Xenon 70% (65%-75%) in Oxygen (25%-35%) Receives: Drug: Xenon |
| Group C | Active comparator | Medical Air in Oxygen (45%-55%) Receives: Drug: Medical Air in Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Maintenance period (1 Day)
Secondary outcomes (12)
Anaesthesia Recovery Time
Time interval between the end of maintenance period and time of tracheal tube removal.
Measured: 1 Postoperative Day
Awakening Time
Time interval between the end of maintenance period and time of Aldrete score ≥ 9.
Measured: 1 Postoperative Day
Stay in the Operating Room
Time interval between admission in the operating room and discharge from the operating room.
Measured: 1 Postoperative Day
Stay in the Recovery Room
Time interval between admission in the recovery room and discharge from the recovery room.
Measured: 1 Postoperative Day
Haematology - Leucocytes (Giga/L)
Leucocytes (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery.
Measured: 1 Postoperative Day
Haematology - Erythrocytes (Tera/L)
Erythrocytes (Tera/L) obtained from blood samples collected at baseline and in the morning following surgery.
Measured: 1 Postoperative Day.
Haematology - Platelets (Giga/L)
Platelets (Giga/L) obtained from blood samples collected at baseline and in the morning following surgery
Measured: 1 Postoperative Day
Serum Chemistry - AST (GOT) (IU/L)
AST (GOT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery.
Measured: 1 Postoperative Day
Serum Chemistry - ALT (GPT) (IU/L)
ALT (GPT) (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Measured: 1 Postoperative Day
Serum Chemistry - Gamma GT (IU/L)
Gamma GT (IU/L) obtained from blood samples collected at baseline and in Morning following surgery
Measured: 1 Postoperative Day
Serum Chemistry - Creatinine (Mcmol/L)
Creatinine (mcmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Measured: 1 Postoperative Day
Serum Chemistry - Urea (mmol/L)
Urea (mmol/L) obtained from blood samples collected at baseline and in Morning following surgery
Measured: 1 Postoperative Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Berthold BEIN, Prof Dr Med, Principal investigator, University Hospital Schleswig-HolsteinJens SCHOLZ, Prof. Dr Med, Study chair, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919126
- Sponsor's protocol ID
- ALMED-07-C3-007
- Other IDs
- 2007-001979-10
- Status last verified
- Sep 2014
- First submitted
- 11 Jun 2009
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00919126
- Acronym / sponsor ID
- ALMED-07-C3-007
- Conditions
- Anaesthesia
- Keywords
- Xenon in Anaesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Air Liquide SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 17 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: XenonXenon 50% (45%-55%) in Oxygen (45%-55%), |
| Group B | Experimental | Drug: XenonXenon 70% (65%-75%) in Oxygen (25%-35%) |
| Group C | Active comparator | Drug: Medical Air in OxygenMedical Air in Oxygen (45%-55%) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XenonMaintenance of anaesthesia obtained with Xenon 50% and propofol infusion adjusted to depth of anaesthesia. | Drug | Group A |
| XenonMaintenance of anaesthesia obtained with Xenon 70% and propofol infusion adjusted to depth of anaesthesia. | Drug | Group B |
| Medical Air in OxygenMaintenance of anaesthesia obtained with propofol infusion adjusted to depth of anaesthesia. | Drug | Group C |
Primary outcome
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min)
Time frame: 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.
12 secondary outcomes
Anaesthesia Recovery Time
Time frame: 1 Postoperative Day
Awakening Time
Time frame: 1 Postoperative Day
Stay in the Operating Room
Time frame: 1 Postoperative Day
Stay in the Recovery Room
Time frame: 1 Postoperative Day
Haematology - Leucocytes (Giga/L)
Time frame: 1 Postoperative Day
Haematology - Erythrocytes (Tera/L)
Time frame: 1 Postoperative Day.
Haematology - Platelets (Giga/L)
Time frame: 1 Postoperative Day
Serum Chemistry - AST (GOT) (IU/L)
Time frame: 1 Postoperative Day
Serum Chemistry - ALT (GPT) (IU/L)
Time frame: 1 Postoperative Day
Serum Chemistry - Gamma GT (IU/L)
Time frame: 1 Postoperative Day
Serum Chemistry - Creatinine (Mcmol/L)
Time frame: 1 Postoperative Day
Serum Chemistry - Urea (mmol/L)
Time frame: 1 Postoperative Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold BEIN, Prof Dr Med principal investigator
University Hospital Schleswig-Holstein
Jens SCHOLZ, Prof. Dr Med study chair
University Hospital Schleswig-Holstein
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon and Medical Air in Oxygen in people with Anaesthesia, run by Air Liquide SA at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Propofol (mg) Administered During Maintenance Adjusted to Patient Body Surface Area (BSA in m²) and Maintenance Duration (Min) (time frame: Maintenance period (1 Day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.