Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting. A Prospective, Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Accuracy of Values Between Tetragraph and ToFscan
研究概览
简要总结
Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > or = 18 years old
- •Patients willing to participate and provide an informed consent
- •Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.
排除标准
- •Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
- •Patients with systemic neuromuscular diseases such as myasthenia gravis
- •Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
- •Patients having surgery that would involve prepping the arm or leg into the sterile field
研究组 & 干预措施
Dominant hand
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
干预措施: Tetragraph (Device)
Dominant hand
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand, ToFscan placed on non-dominant hand
干预措施: ToFscan (Device)
Non-dominant hand
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
干预措施: Tetragraph (Device)
Non-dominant hand
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand, ToFscan placed on dominant hand
干预措施: ToFscan (Device)
结局指标
主要结局
Accuracy of Values Between Tetragraph and ToFscan
时间窗: Up to 1 hour postoperatively
The number of subject's who's residual neuromuscular blockage units are the same on both the TetraGraph and the ToFscan
次要结局
- Incidence of Residual Neuromuscular Blockade(Up to 1 hour postoperatively)
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic