Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- MEP amplitude
研究概览
简要总结
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
详细描述
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 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)
研究组 & 干预措施
Cisatracurium Group
MEP monitoring with continuous infusion of cisatracurium during general anesthesia
干预措施: MEP monitoring with continuous infusion of cisatracurium during general anesthesia (Other)
Vecuronium Group
MEP monitoring with continuous infusion of vecuronium during general anesthesia
干预措施: MEP monitoring with continuous infusion of vecuronium during general anesthesia (Other)
结局指标
主要结局
MEP amplitude
时间窗: 300 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
次要结局
- Average of MEP amplitudes(at the end of the surgery (5H after the start of surgery))
- Average of Latency of MEP amplitude(at the end of the surgery (5H after the start of surgery))
- Coefficient of variation (CV) of MEP amplitude(at the end of the surgery (5H after the start of surgery))
- The frequency of adjusting the infusion dose of muscle relaxant(at the end of the surgery (5H after the start of surgery))
研究者
Jeong Jin Lee
Professor
Samsung Medical Center