Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01404819
First received: July 27, 2011
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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).


Condition Intervention
Carotid Endarterectomy
Drug: Anesthesia with Xenon
Drug: Standard anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Presence/absence of S100B > 0.2 ng/ml during surgery [ Time Frame: During surgery (expected mean time of around 120 minutes) ] [ Designated as safety issue: No ]
    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 [ Time Frame: end of surgery (expected mean of 120 minutes) ] [ Designated as safety issue: No ]
    The change in S100 calcium binding protein B concentration before and after surgery (ng/ml)

  • NSE change from baseline [ Time Frame: end of surgery (expected mean of 2 hours), just before clamp removal ] [ Designated as safety issue: No ]
    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 [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    The change in Neuron Specific Enolase (NSE) between a preoperative measurement and a second measurement just after surgery

  • Change in troponine from baseline [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Change in tropinine between preoperative and postoperative measurements

  • Change in creatinemia from baseline [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Change in creatinemia between preoperative and postoperative measurements

  • Change in creatine clearance from baseline [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Change in creatine clearance (MDRD equation) between preoperative and postoperative measurements

  • Change NIHSS score from baseline [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Change in the National Institute of Health Stroke Score (NIHSS) between preoperative and postoperative measurements

  • Number of transfusions [ Time Frame: During surgery (estimated mean of 120 minutes) ] [ Designated as safety issue: Yes ]
    Number of transfused red blood cell packs

  • Direct costs [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Direct costs (€) incurred

  • Indirect costs [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The indirect costs (€) incurred


Estimated Enrollment: 86
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404819

Contacts
Contact: Jacques Ripart, MD PhD +33.(0)4.66.68.30.50 jacques.ripart@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
Centre Hospitalier Universitaire de Nîmes Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Jacques Ripart, MD PhD         
Sub-Investigator: Grégory Coin         
Sub-Investigator: Jean-Paul Brouillet         
Sub-Investigator: Lana Zoric, MD         
Sub-Investigator: Jésus Diaz, MD         
Sub-Investigator: Sophie Debureaux, MD         
Sub-Investigator: Eric Picard, MD         
Sub-Investigator: Pascal Branchereau, MD         
Sub-Investigator: Catalin Cosma, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jacques Ripart, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01404819     History of Changes
Other Study ID Numbers: LOCAL/2011/JRGC, 2011-002551-33
Study First Received: July 27, 2011
Last Updated: April 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Inhalation
Anesthetics, General
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Xenon
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014