NCT01404819已完成不适用
Evaluation of Brain Damage Resulting From Carotid Endarterectomy With Xenon Anesthesia
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Presence/absence of S100B > 0.2 ng/ml during surgery
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental arm
Experimental
Patients in this arm undergo anesthesia with Xenon.
干预措施: Anesthesia with Xenon (Drug)
Standard arm
Active Comparator
Patients in this arm undergo standard anesthesia
干预措施: Standard anesthesia (Drug)
结局指标
主要结局
Presence/absence of S100B > 0.2 ng/ml during surgery
时间窗: 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
次要结局
- 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)
研究者
研究点 (1)
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