Clinical trial NCT01404819: Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
Official title: Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Endarterectomy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of S100B > 0.2 ng/ml during surgery
timeFrame: During surgery (expected mean time of around 120 minutes)
Secondary outcomes:
measure: S100B change relative to baseline
timeFrame: end of surgery (expected mean of 120 minutes)
measure: NSE change from baseline
timeFrame: end of surgery (expected mean of 2 hours), just before clamp removal
measure: NSE change from baseline
timeFrame: end of surgery (expected mean of 2 hours)
measure: Change in troponine from baseline
timeFrame: end of surgery (expected mean of 2 hours)
measure: Change in creatinemia from baseline
timeFrame: end of surgery (expected mean of 2 hours)
measure: Change in creatine clearance from baseline
timeFrame: end of surgery (expected mean of 2 hours)
measure: Change NIHSS score from baseline
timeFrame: end of surgery (expected mean of 2 hours)
measure: Number of transfusions
timeFrame: During surgery (estimated mean of 120 minutes)
measure: Direct costs
timeFrame: 2 days
measure: Indirect costs
timeFrame: 2 days
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jacques Ripart, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: