Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia

NCT01404819 | Completed DMC

• 2 other identifiers: LOCAL/2011/JRGC2011-002551-33
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Carotid Endarterectomy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (10)

• S100B change relative to baseline

  end of surgery (expected mean of 120 minutes)

• NSE change from baseline

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

• NSE change from baseline

  end of surgery (expected mean of 2 hours)

• Change in troponine from baseline

  end of surgery (expected mean of 2 hours)

• Change in creatinemia from baseline

  end of surgery (expected mean of 2 hours)

Study Arms (2)

Experimental arm

EXPERIMENTAL

Patients in this arm undergo anesthesia with Xenon.

Drug: Anesthesia with Xenon

Standard arm

ACTIVE COMPARATOR

Patients in this arm undergo standard anesthesia

Drug: Standard anesthesia

Interventions

Anesthesia with Xenon DRUG

Patients undergo anesthesia with xenon (remifentanil with xenon).

Experimental arm

Standard anesthesia DRUG

Patients undergo standard anesthesia (remifentanil with propofol)

Standard arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Interventions

Anesthesia; Xenon

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Noble Gases; Elements; Inorganic Chemicals; Gases

Study Officials

• Jacques Ripart, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 28, 2011
• Study Start: April 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 27, 2015

Record last verified: 2015-03

Locations

FR (1)