Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- Anesthesia with Xenon
- Conditions
- Carotid Endarterectomy
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Presence/absence of S100B > 0.2 ng/ml during surgery
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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).
Investigators
Eligibility 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
Arms & Interventions
Experimental arm
Patients in this arm undergo anesthesia with Xenon.
Intervention: Anesthesia with Xenon
Standard arm
Patients in this arm undergo standard anesthesia
Intervention: Standard anesthesia
Outcomes
Primary Outcomes
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
- 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))
- 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))
- Change in creatine clearance from baseline(end of surgery (expected mean of 2 hours))
- Change NIHSS score from baseline(end of surgery (expected mean of 2 hours))
- Number of transfusions(During surgery (estimated mean of 120 minutes))
- Direct costs(2 days)
- Indirect costs(2 days)