Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

NCT ID: NCT01404819

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-02-28

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).

Conditions

Carotid Endarterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental arm

Patients in this arm undergo anesthesia with Xenon.

Group Type: EXPERIMENTAL

Anesthesia with Xenon

Intervention Type: DRUG

Patients undergo anesthesia with xenon (remifentanil with xenon).

Standard arm

Patients in this arm undergo standard anesthesia

Group Type: ACTIVE_COMPARATOR

Standard anesthesia

Intervention Type: DRUG

Patients undergo standard anesthesia (remifentanil with propofol)

Interventions

Anesthesia with Xenon

Patients undergo anesthesia with xenon (remifentanil with xenon).

Intervention Type: DRUG

Standard anesthesia

Patients undergo standard anesthesia (remifentanil with propofol)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Ripart, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, France

Countries

France

Other Identifiers

2011-002551-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LOCAL/2011/JRGC

Identifier Type: -

Identifier Source: org_study_id