NCT00226018已完成4 期
Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The precision of acceleromyography with and without preload during recovery
研究概览
简要总结
The purpose of this study is to examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •General anesthesia > 1 hour
- •Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
- •Written informed content
排除标准
- •Neuromuscular disorders, hepatic and renal dysfunction
- •Medication expected to interfere with the neuromuscular blocking agent
- •Allergy to any medication used during anesthesia
- •Body weight less or exceeding 20% of the ideal body weight
- •Pregnancy or breastfeeding
研究组 & 干预措施
4
Placebo Comparator
Acceleromygraphy without Hand Adapter on non-dominant arm
干预措施: Placebo (Device)
1
Active Comparator
Acceleromyography with Hand Adapter on dominant arm
干预措施: Hand Adapter (Organon, Oss, the Netherlands) (Device)
2
Active Comparator
Acceleromyography with Hand Adapter on non-dominant arm
干预措施: Hand Adapter (Organon, Oss, the Netherlands) (Device)
3
Placebo Comparator
Acceleromyography without Hand Adapter on dominant arm
干预措施: Placebo (Device)
结局指标
主要结局
The precision of acceleromyography with and without preload during recovery
次要结局
- Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
- All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":
- Bias og limits of agreement between control TOF
- Onset time
- Time to reappearance of T1, T2, T3 and T4
- Twitch height of T1 at reappearance of T1, T2, T3 and T4
- Time to T1=25%
- Interval 25-75%
- Time to TOF-ratio = 0.9 and 1.0
- Time to final T1
- Time to final TOF ratio
研究者
研究点 (1)
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