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Completed

NCT Number: NCT01404819

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthesia with Xenon

Drug

Patients undergo anesthesia with xenon (remifentanil with xenon).

standard anesthesia

Drug

Patients undergo standard anesthesia (remifentanil with propofol)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Change in troponine from baseline

    Time frame: end of surgery (expected mean of 2 hours)

    Change in tropinine between preoperative and postoperative measurements

  5. Change in creatinemia from baseline

    Time frame: end of surgery (expected mean of 2 hours)

    Change in creatinemia between preoperative and postoperative measurements

  6. 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

  7. 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

  8. Number of transfusions

    Time frame: During surgery (estimated mean of 120 minutes)

    Number of transfused red blood cell packs

  9. Direct costs

    Time frame: 2 days

    Direct costs (€) incurred

  10. Indirect costs

    Time frame: 2 days

    The indirect costs (€) incurred

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2011
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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