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Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Primary Purpose

Carotid Endarterectomy

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Anesthesia with Xenon

Standard anesthesia

About this trial

This is an interventional prevention trial for Carotid Endarterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Universitaire de Nîmes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Standard arm

Arm Description

Patients in this arm undergo anesthesia with Xenon.

Patients in this arm undergo standard anesthesia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

S100B change relative to baseline

The change in S100 calcium binding protein B concentration before and after surgery (ng/ml)

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

NSE change from baseline

The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery

Change in troponine from baseline

Change in tropinine between preoperative and postoperative measurements

Change in creatinemia from baseline

Change in creatinemia between preoperative and postoperative measurements

Change in creatine clearance from baseline

Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements

Change NIHSS score from baseline

Change in the National Institute of Health Stroke Score (NIHSS) between preoperative and postoperative measurements

Number of transfusions

Number of transfused red blood cell packs

Direct costs

Direct costs (€) incurred

Indirect costs

The indirect costs (€) incurred

Full Information

NCT ID

NCT01404819

First Posted

July 27, 2011

Last Updated

March 26, 2015

Sponsor

Centre Hospitalier Universitaire de Nīmes

1. Study Identification

Unique Protocol Identification Number

NCT01404819

Brief Title

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Endarterectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

Patients in this arm undergo anesthesia with Xenon.

Arm Title

Standard arm

Arm Type

Active Comparator

Arm Description

Patients in this arm undergo standard anesthesia

Intervention Type

Drug

Intervention Name(s)

Anesthesia with Xenon

Intervention Description

Patients undergo anesthesia with xenon (remifentanil with xenon).

Intervention Type

Drug

Intervention Name(s)

Standard anesthesia

Intervention Description

Patients undergo standard anesthesia (remifentanil with propofol)

Primary Outcome Measure Information:

Title

Presence/absence of S100B > 0.2 ng/ml during surgery

Description

Presence/absence of S100 calcium binding protein B concentration after induction and before the removal of the radial arterial catheter clamp placed before induction

Time Frame

During surgery (expected mean time of around 120 minutes)

Secondary Outcome Measure Information:

Title

S100B change relative to baseline

Description

The change in S100 calcium binding protein B concentration before and after surgery (ng/ml)

Time Frame

end of surgery (expected mean of 120 minutes)

Title

NSE change from baseline

Description

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

Time Frame

end of surgery (expected mean of 2 hours), just before clamp removal

Title

NSE change from baseline

Description

The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery

Time Frame