NCT01142648已完成4 期
The Effect of Sugammadex of EEG-derived Index Values
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The behaviour of depth of anaesthesia indexes (BIS,SE,RE)
研究概览
简要总结
According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.
详细描述
Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females giving informed consent
- •age range 18-65 years
- •elective surgery: gynaecological
- •general anaesthesia
- •ASA classification 1 or 2
排除标准
- •pregnancy
- •body mass index > 30
- •disease affecting CNS
- •overuse of alcohol
- •drug abuse
- •unability to understand, read or use Finnish language
结局指标
主要结局
The behaviour of depth of anaesthesia indexes (BIS,SE,RE)
时间窗: 30 minutes
次要结局
- The behaviour of electroencephalography(30 minutes)
研究者
研究点 (1)
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