NCT01199276已完成2 期
An International, Multi-center, Randomized, Controlled Trial Evaluating The Effect of Xenon on Post-operative Delirium in Elderly Patients Undergoing Hip Fracture Surgery
Air Liquide Santé International13 个研究点 分布在 6 个国家目标入组 256 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 13
- 主要终点
- Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
研究概览
简要总结
The objective of this study is to evaluate the incidence of Post-Operative Delirium (POD), diagnosed with the Confusion Assessment Method (CAM), in elderly patients undergoing hip fracture surgery under general anaesthesia with xenon or sevoflurane, for a period of four days post-surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patient (≥ 75 years)
- •Patient with planned hip fracture surgery within 48 hours after the hip fracture
- •Patient willing and able to complete the requirements of this study including the signature of the written informed consent
排除标准
- •Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur)
- •Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression)
- •Brain trauma within 12 months prior to selection, history of stroke with residuals
- •Patient suffering from delirium (CAM diagnosis) at selection
- •Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial
- •Patient with Mini-Mental State Examination (MMSE) score < 24 at selection
- •Patient known to susceptible to malignant hyperthermia
- •Patient with elevated intra-cranial pressure
- •Patient with a risk of high oxygen demand
- •Patient with recent or ongoing myocardial infarction / damage
- •Patient with severe cardiac failure, or patient with severe impaired left ventricular systolic function
- •Patient with known severe lung and/or airway disease, or severe chronic respiratory insufficiency, or a sustained homecare oxygen therapy
- •Contra-indication (serious illness or medical conditions) for general anaesthesia
- •Known allergy or hypersensitivity to any drugs administered during this clinical trial
- •Previous participation in this clinical trial
- •Participation in another clinical trial within 4 weeks prior to selection
- •History of alcohol or drug abuse or psychiatric disorders which would impair the understanding of the necessary information or render medically or legally unable to give written informed consent
研究组 & 干预措施
Xenon
Experimental
60%(1MAC)in oxygen (FiO2 = 0.35-0.45)
干预措施: Xenon (Drug)
Sevoflurane
Active Comparator
1.1-1.4% (1 MAC) in oxygen (FiO2 = 0.35-0.45) and medical air
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Post Operative Delirium diagnosed with the Confusion Assessment Method within four days post-surgery
时间窗: Four days
次要结局
- Recovery Parameters(fifteen minutes)
- Post Operative Delirium diagnosed with the Confusion Assessment Method from day 5 post surgery to discharge from hospital(About 7 days)
- Sequential Organ Failure Assessment from day 1 to day 4 post-surgery(four days)
- economic parameters(up to thirty days)
- Safety Parameters(Up to thirty days)
研究者
研究点 (13)
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