Carotid EndarterectomyNCT01404819
Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
A study testing Anesthesia with Xenon and Standard anesthesia in people with Carotid Endarterectomy, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy
- What is being tested?
- Anesthesia with Xenon and Standard anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2012to Feb 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patients with American Society of Anesthesiology (ASA) scores of 1 to 4
- Patient schelduled for carotid endarterectomy
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
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- The patient is breastfeeding
- The patient has a contra-indication for a treatment necessary for this study
- The endarterectomy does not require a shunt
- ASA score of 5
- Patient presenting with symptomatic gastric-oesophagien reflux
- Patient has neuro-endocrine cancer
- Patient has hypersensivity to one of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, senon, paracetamol, tramadol
- Patient suffering from obstructive respiratory insufficiency (chronic obstructive pulmonary disease, asthma)
- Patient with coronary disease with severely altered cardiac function
- High intracranial pressure
- Patient requiring high concentrations of oxygen (SpO2 < 92% normal air)
- Patient with neuro-sensorial deficit that, in the absence of a prothesis, prevents reading, writing, or responding to simple orders
- Patient suffering from myopathy or recent rhabdomyolysis
- Patient with psychiatric pathology or chronic alcohol consumption or consumption of another substance that interferes with understanding
- Lack of contraception for women of child-bearing age
- History of or suspected malignant hyperthermia
- Patients with liver damage, jaundice, unexplained fever or eosinophilia after administration of a halogenated anesthetic
- Patient has undergone a recent multiple trauma (<1 month)
- Patient who received general anesthesia within the past 7 days
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).
- Conditions
- Carotid Endarterectomy
- Being tested
- Anesthesia with Xenon, Standard anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia with XenonDrug
Patients undergo anesthesia with xenon (remifentanil with xenon).
Standard anesthesiaDrug
Patients undergo standard anesthesia (remifentanil with propofol)
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients in this arm undergo anesthesia with Xenon. Receives: Drug: Anesthesia with Xenon |
| Standard arm | Active comparator | Patients in this arm undergo standard anesthesia Receives: Drug: Standard anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of S100B > 0.2 ng/ml during surgery
Presence/absence of S100 calcium binding protein B concentration after induction and before the removal of the radial arterial catheter clamp placed before induction
Measured: During surgery (expected mean time of around 120 minutes)
Secondary outcomes (10)
S100B change relative to baseline
The change in S100 calcium binding protein B concentration before and after surgery (ng/ml)
Measured: end of surgery (expected mean of 120 minutes)
NSE change from baseline
The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement near the end of surgery and just before clamp removal
Measured: end of surgery (expected mean of 2 hours), just before clamp removal
NSE change from baseline
The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery
Measured: end of surgery (expected mean of 2 hours)
Change in troponine from baseline
Change in tropinine between preoperative and postoperative measurements
Measured: end of surgery (expected mean of 2 hours)
Change in creatinemia from baseline
Change in creatinemia between preoperative and postoperative measurements
Measured: end of surgery (expected mean of 2 hours)
Change in creatine clearance from baseline
Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements
Measured: end of surgery (expected mean of 2 hours)
Change NIHSS score from baseline
Change in the National Institute of Health Stroke Score (NIHSS) between preoperative and postoperative measurements
Measured: end of surgery (expected mean of 2 hours)
Number of transfusions
Number of transfused red blood cell packs
Measured: During surgery (estimated mean of 120 minutes)
Direct costs
Direct costs (€) incurred
Measured: 2 days
Indirect costs
The indirect costs (€) incurred
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startApr 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid EndarterectomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Ripart, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404819
- Sponsor's protocol ID
- LOCAL/2011/JRGC
- Other IDs
- 2011-002551-33
- Status last verified
- Mar 2015
- First submitted
- 27 Jul 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
- ClinicalTrials.gov ID
- NCT01404819
- Acronym / sponsor ID
- LOCAL/2011/JRGC
- Conditions
- Carotid Endarterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 28 Jul 2011 (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 objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of S100B before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with Xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Anesthesia with XenonPatients in this arm undergo anesthesia with Xenon. |
| Standard arm | Active comparator | Drug: Standard anesthesiaPatients in this arm undergo standard anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patients with American Society of Anesthesiology (ASA) scores of 1 to 4
- Patient schelduled for carotid endarterectomy
Key exclusion criteria (25 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Anesthesia with XenonPatients undergo anesthesia with xenon (remifentanil with xenon). | Drug | Experimental arm |
| Standard anesthesiaPatients undergo standard anesthesia (remifentanil with propofol) | Drug | Standard arm |
Primary outcome
Presence/absence of S100B > 0.2 ng/ml during surgery
Time frame: During surgery (expected mean time of around 120 minutes)
Presence/absence of S100 calcium binding protein B concentration after induction and before the removal of the radial arterial catheter clamp placed before induction
10 secondary outcomes
S100B change relative to baseline
Time frame: end of surgery (expected mean of 120 minutes)
NSE change from baseline
Time frame: end of surgery (expected mean of 2 hours), just before clamp removal
NSE change from baseline
Time frame: end of surgery (expected mean of 2 hours)
Change in troponine from baseline
Time frame: end of surgery (expected mean of 2 hours)
Change in creatinemia from baseline
Time frame: end of surgery (expected mean of 2 hours)
Change in creatine clearance from baseline
Time frame: end of surgery (expected mean of 2 hours)
Change NIHSS score from baseline
Time frame: end of surgery (expected mean of 2 hours)
Number of transfusions
Time frame: During surgery (estimated mean of 120 minutes)
Direct costs
Time frame: 2 days
Indirect costs
Time frame: 2 days
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 27 Mar 2015.
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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.
Jacques Ripart, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia with Xenon and Standard anesthesia in people with Carotid Endarterectomy, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 25 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 27 Mar 2015. 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.
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?
Presence/absence of S100B > 0.2 ng/ml during surgery (time frame: During surgery (expected mean time of around 120 minutes)). 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 27 Mar 2015.