ACTRN12605000150640已完成3 期
The prospective randomised controlled phase III GRAIL Trial will consider patients receiving general anaesthesia compared to those receiving regional anaesthesia to undergo extracorporeal shock wave lithotripsy for the treatment of kidney stones and will evaluate whether there is any difference in the incidence of postoperative cognitive dysfunction (POCD) in the short and medium term.
Dr. Brendan Silbert0 个研究点目标入组 200 人开始时间: 2005年8月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Patients who are scheduled for elective ESWL, do not have neurological deficit, give written informed consent and have no contraindication to neuropsychological testing. The patients must reside in accessible proximity to the hospital to enable investigators to administer testing at home.
排除标准
- •1. Pre-existing neurological or neurovascualr disease (eg. stroke); 2. Score of less than 24 on the Mini Mental State Examination (MMSE); 3. Anticipated difficulty with neuropsychologcail assessment such as English not being the prime language, blindness, deafness; 4. Associated medical problems that may lead to significant complications and subsequent loss to follow-up (ASA Physical Status IV or higher); 5. Contraindication to spinal anaesthesia (eg. anti-coagulation therapy or bleeding tendency); 6. Body Mass Index (BMI) greater than 35.
研究者
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