Hemodynamic StabilityPhase 4NCT00937807
Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
A Phase 4 study testing xenon and sévoflurane in people with Hemodynamic Stability, run by Air Liquide Santé International at 1 site in France.
Trial summary
The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hemodynamic Stability
- What is being tested?
- xenon and sévoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 55 years, status ASA II
- Carotid endarterectomy elected surgery
- Signed informed consent
Who cannot join
- Related to the patients:
- Histories of hypersensibility in both products used in the study
- uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
- Severe cardiac failure (FEVG < 30 %)
- Major lung or airways disease and\or required per-operating FiO2> 35 %
- Elevated intracranial pressure
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- Pregnancy, breast feeding
- Major protected, under supervision, under guardianship
- Every patient entering within the framework of the contraindications indicated to §4.3 of the summary of the characteristics of tested products (LENOXe ™ (xenon 100 % v/v), sevoflurane)
- Related to the surgery:
- Controlateral carotid stenosis superior to 70 % and\or preoperative indication in the implementation per-operating of a carotid shunt
- Surgery realized within the framework of an emergency
- Combined Surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE
The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.
- Conditions
- Hemodynamic Stability
- Being tested
- xenon, sévoflurane
- Keywords
- hemodynamic stability, xenon, carotid surgery, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xenonDrug
Inhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
sévofluraneDrug
Inhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery
| Study group | Role | What they receive |
|---|---|---|
| sévoflurane | Active comparator | hypnotic use in standard general anesthesia Receives: Drug: sévoflurane |
| LENOXe™ (xénon 100 % v/v) | Experimental | Safety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person Receives: Drug: xenon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used
Measured: Pre-op, every min from 1-90 min during maintenance phase
Secondary outcomes (1)
cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient
Measured: During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic StabilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Responsible party
- Sponsor
- Investigators
- Pierre CORIAT, Pr, Principal investigator, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937807
- Sponsor's protocol ID
- ALS-8-09-A-401
- Other IDs
- EUDRACT 2009-012810-29
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2009
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hemodynamic stability of xenon during general anaesthesia for carotid endariectomia in old patientsJune 2011European Journal of Anaesthesiology 28:45DOI:10.1097/00003643-201106001-00138 Yannick Le Manach, G. DouffléJ. P. Goarin, Irene Santos Cristina
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE
- ClinicalTrials.gov ID
- NCT00937807
- Acronym / sponsor ID
- ALS-8-09-A-401
- Conditions
- Hemodynamic Stability
- Keywords
- hemodynamic stability, xenon, carotid surgery, general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- Study start
- Jul 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
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 compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sévoflurane | Active comparator | Drug: sévofluranehypnotic use in standard general anesthesia |
| LENOXe™ (xénon 100 % v/v) | Experimental | Drug: xenonSafety of use in terms of hemodynamic stability to the LENOXe™ (xénon 100 % v/v) within the framework of the carotid surgery on the old person |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 55 years, status ASA II
- Carotid endarterectomy elected surgery
- Signed informed consent
Key exclusion criteria (13 listed)
- Histories of hypersensibility in both products used in the study
- uncontrolled arterial High Blood Pressure in the preoperative anaesthesia screening
- Severe cardiac failure (FEVG < 30 %)
- Major lung or airways disease and\or required per-operating FiO2> 35 %
- Elevated intracranial pressure
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 |
|---|---|---|
| xenonInhalational gas; dose allowed: 60 % Xenon; the duration of the treatment will be defined through anesthesia-time for a carotid surgery | Drug | LENOXe™ (xénon 100 % v/v) |
| sévofluraneInhalation gas; dose allowed: 1,4 %; the duration of the treatment will be defined through anesthesia-time for a carotid surgery | Drug | sévoflurane |
Primary outcome
Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used
Time frame: Pre-op, every min from 1-90 min during maintenance phase
1 secondary outcome
cardiovascular, general, hepatic and renal tolerance to xenon. Quality and time of awakening, recovery index (IR);Post-op pain (EVA)and consumption of analgesic; Inflammatory Syndrome (cytokine profile); Subjective comfort of the patient
Time frame: During the whole anesthetic procedure and the postoperating time until 24 hours after discharge from the recovery room / intensive care unit and return to the ward
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publicationHemodynamic stability of xenon during general anaesthesia for carotid endariectomia in old patientsJune 2011European Journal of Anaesthesiology 28:45DOI:10.1097/00003643-201106001-00138 Yannick Le Manach, G. DouffléJ. P. Goarin, Irene Santos Cristina
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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.
Pierre CORIAT, Pr principal investigator
Groupe Hospitalier Pitie-Salpetriere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing xenon and sévoflurane in people with Hemodynamic Stability, run by Air Liquide Santé International at 1 site in France.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Standard deviation of the values of systolic blood pressure (SBP)collected per-operatively every minutes(BIOPAC ® MP150) Values of SBP over or under thresholds during and out of the clamping period, if so vasopressive/ hypotensive treatment used (time frame: Pre-op, every min from 1-90 min during maintenance phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937807, which also lists 1 linked publication.
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 11 Sep 2025.