Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Conditions
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Carotid Endarterectomy

Intervention / Treatment
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* Drug: Anesthesia with Xenon
* Drug: Standard anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>Patients in this arm undergo anesthesia with Xenon. | Drug: Anesthesia with Xenon<br>* Patients undergo anesthesia with xenon (remifentanil with xenon).<br>|
| Active Comparator: Standard arm<br>Patients in this arm undergo standard anesthesia | Drug: Standard anesthesia<br>* Patients undergo standard anesthesia (remifentanil with propofol)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | During surgery (expected mean time of around 120 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| S100B change relative to baseline | The change in S100 calcium binding protein B concentration before and after surgery (ng/ml) | 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 | 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 | end of surgery (expected mean of 2 hours) | 
| Change in troponine from baseline | Change in tropinine between preoperative and postoperative measurements | end of surgery (expected mean of 2 hours) | 
| Change in creatinemia from baseline | Change in creatinemia between preoperative and postoperative measurements | 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 | 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 | end of surgery (expected mean of 2 hours) | 
| Number of transfusions | Number of transfused red blood cell packs | During surgery (estimated mean of 120 minutes) | 
| Direct costs | Direct costs (€) incurred | 2 days | 
| Indirect costs | The indirect costs (€) incurred | 2 days |