Effect of Sugammadex Versus Neostigmine/Atropine Combination on Cognitive Function After Elective Adult Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in the Mini-Mental State Evaluation test
研究概览
简要总结
Post operative cognitive dysfunction (POCD) is recognized as a frequent complication after both cardiac and non cardiac surgery, affecting approximately 1/3 of the patients. The aim of this study is to examine the possible effect of the novel reversal agent sugammadex versus neostigmine/ atropine combination on cognitive function of adult patients after elective surgery during the early post operative period as well as at discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged >40 years old
- •ASA I-III
- •Patients scheduled for elective surgery with general anaesthesia.
排除标准
- •Neuro-, vascular-, orthopedic- or cardiac surgery
- •Known psychiatric or disease of the CNS
- •History of craniotomy
- •Receiving tranquillisers or antidepressants on a regular basis pre-operatively
- •Alcoholism or drug dependence
- •History of stroke
- •Refusal of patient
- •Inability to read or write
- •MMSE < 22 pre-operatively
研究组 & 干预措施
Sugammadex
Sugammadex is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
干预措施: Sugammadex (Drug)
Neostigmine/atropine
Neostigmine combined to atropine is administered to reverse rocuronium-induced neuromuscular blockade at the end of elective surgery.
干预措施: Neostigmine/atropine (Drug)
结局指标
主要结局
Change in the Mini-Mental State Evaluation test
时间窗: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the clock-drawing test
时间窗: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
Change in the Isaacs set test
时间窗: Preoperatively, 1 hour postoperatively, at discharge (1-15 days postoperatively)
次要结局
- Time from reversal agent administration to extubation(After reversal agent administration)
研究者
Chrysanthi Batistaki
Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens
Attikon Hospital