Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Not Applicable

Completed

• Conditions: Carotid Endarterectomy
• Interventions: Drug: Anesthesia with Xenon; Drug: Standard anesthesia

• Registration Number: NCT01404819
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Study Start: 2012-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Anesthesia with Xenon	Patients in this arm undergo anesthesia with Xenon.
Standard arm	Standard anesthesia	Patients in this arm undergo standard anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
NSE change from baseline	end of surgery (expected mean of 2 hours)	The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery
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
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
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
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France