Determination of ED50 and ED95 of Vecuronium Infusion Dose for Maintaining Response of Train of Four Less Than 2 During the MEP Monitoring for Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Amplitude of MEP monitoring
研究概览
简要总结
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland).
详细描述
The maintenance of partial neuromuscular blocking during general anesthesia for neurosurgery is essential for intraoperative motor-evoked potential monitoring. However, the precise strategy of administering neuromuscular blocking agent for obtaining that goal has not been established. Therefore, the investigators tried to find the optimal initial dose of vecuronium infusion and determine the adequate goal of neuromuscular blocking as guided by neuromuscular transmission module (M-NMT Module, Datex-Ohmeda Inc, Helsinki, Finland). Previously, one to two counts of response to TOF stimulation has been considered to be primary goal of partial neuromuscular blocking needed for intraoperative motor evoked potential monitoring. However, the visualization of twitch height of response to TOF stimulation has been possible with the help of NMT module. For adequate motor evoked potential monitoring, twitch height of T1 or T2 is also as important as simple count of TOF stimulation. The investigators tried to establish a vecuronium infusion strategy as guided by not only count of TOF stimulation but also twitch height of T1 or T2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
排除标准
- •Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
- •Patients with hepatic or renal disease with altered metabolism of vecuronium
- •Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
结局指标
主要结局
Amplitude of MEP monitoring
时间窗: every 30 min during MEP monitoring
the value of MEP amplitude every 30 min during MEP monitoring
次要结局
- latency of MEP monitoring(every 30 min during MEP monitoring)
- Incidence of patient's spontaneous movement(from start to end of the MEP monitoring, an expected average of 4 hours)
- Overall assessment of MEP monitoring quality(from start to end of the MEP monitoring, an expected average of 4 hours)
- Incidence of patient's spontaneous respiration(from start to end of the MEP monitoring, an expected average of 4 hours)
研究者
Jeong Jin Lee
Professor
Samsung Medical Center