Carotid Endarterectomy
Conditions
Brief 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 associated with propofol (reference arm).
Interventions
DRUGAnesthesia with Xenon
Patients undergo anesthesia with xenon (remifentanil with xenon).
Patients undergo standard anesthesia (remifentanil with propofol)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of S100B > 0.2 ng/ml during surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in creatine clearance from baseline | end of surgery (expected mean of 2 hours) | Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements |
| S100B change relative to baseline | end of surgery (expected mean of 120 minutes) | The change in S100 calcium binding protein B concentration before and after surgery (ng/ml) |
| Change NIHSS score from baseline | end of surgery (expected mean of 2 hours) | Change in the National Institute of Health Stroke Score (NIHSS) between preoperative and postoperative measurements |
| NSE change from baseline | end of surgery (expected mean of 2 hours), just before clamp removal | 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 |
| Change in troponine from baseline | end of surgery (expected mean of 2 hours) | Change in tropinine between preoperative and postoperative measurements |
| Change in creatinemia from baseline | end of surgery (expected mean of 2 hours) | Change in creatinemia between preoperative and postoperative measurements |
| Number of transfusions | During surgery (estimated mean of 120 minutes) | Number of transfused red blood cell packs |
| Direct costs | 2 days | Direct costs (€) incurred |
| Indirect costs | 2 days | The indirect costs (€) incurred |
Countries
France
Outcome results
None listed