Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

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 Overview

• Status: Completed
• Conditions: Carotid Endarterectomy
• Intervention / Treatment: Drug: Anesthesia with Xenon; Drug: Standard anesthesia

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • Centre Hospitalier Universitaire de Nīmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 27, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: LOCAL/2011/JRGC; 2011-002551-33 (EudraCT Number)