Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Carotid Endarterectomy Clinical Trial

Official title:

Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404819
• Other study ID #: LOCAL/2011/JRGC
• Secondary ID: 2011-002551-33
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: March 26, 2015
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Injuries
• Carotid Endarterectomy

Intervention

Drug:
• Anesthesia with Xenon
Patients undergo anesthesia with xenon (remifentanil with xenon).
• Standard anesthesia
Patients undergo standard anesthesia (remifentanil with propofol)

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Nîmes	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	Change in troponine from baseline	Change in tropinine between preoperative and postoperative measurements	end of surgery (expected mean of 2 hours)	No
Secondary	Change in creatinemia from baseline	Change in creatinemia between preoperative and postoperative measurements	end of surgery (expected mean of 2 hours)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Number of transfusions	Number of transfused red blood cell packs	During surgery (estimated mean of 120 minutes)	Yes
Secondary	Direct costs	Direct costs (€) incurred	2 days	No
Secondary	Indirect costs	The indirect costs (€) incurred	2 days	No