Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01404819
First received: July 27, 2011
Last updated: March 26, 2013
Last verified: March 2013
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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: | March 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 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
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 | |
| Sub-Investigator: Jean-Marc Pujol | |
| Sub-Investigator: Jésus Navas | |
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: | March 26, 2013 |
| 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:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Anesthetics |
Xenon Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on May 22, 2013