Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

March 26, 2015 updated by: Centre Hospitalier Universitaire de Nīmes
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence/absence of S100B > 0.2 ng/ml during surgery
Time Frame: 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
During surgery (expected mean time of around 120 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
S100B change relative to baseline
Time Frame: end of surgery (expected mean of 120 minutes)
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
Time Frame: end of surgery (expected mean of 2 hours), just before clamp removal
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
Time Frame: 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
end of surgery (expected mean of 2 hours)
Change in troponine from baseline
Time Frame: end of surgery (expected mean of 2 hours)
Change in tropinine between preoperative and postoperative measurements
end of surgery (expected mean of 2 hours)
Change in creatinemia from baseline
Time Frame: end of surgery (expected mean of 2 hours)
Change in creatinemia between preoperative and postoperative measurements
end of surgery (expected mean of 2 hours)
Change in creatine clearance from baseline
Time Frame: end of surgery (expected mean of 2 hours)
Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements
end of surgery (expected mean of 2 hours)
Change NIHSS score from baseline
Time Frame: end of surgery (expected mean of 2 hours)
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
Time Frame: During surgery (estimated mean of 120 minutes)
Number of transfused red blood cell packs
During surgery (estimated mean of 120 minutes)
Direct costs
Time Frame: 2 days
Direct costs (€) incurred
2 days
Indirect costs
Time Frame: 2 days
The indirect costs (€) incurred
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOCAL/2011/JRGC
  • 2011-002551-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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