NCT07525323Enrolling By Invitation不适用
The Impact Of Electromyography Vs Acceleromyography On The Management Of Neuromuscular Block During Robotic And Laparoscopic Surgery: A Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Cumulative rocuronium dose
研究概览
简要总结
The purpose of this study is to compare the mean cumulative weight-based/time-corrected rocuronium dose administered in patients undergoing robotic- or laparoscopic- assisted surgery using either acceleromyography or electromyography.
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
- Single (Participant)
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 integrated, informed consent
- •Patients undergoing elective laparoscopic- or robotic-assisted surgical procedures
- •Anticipated surgery duration < 300 minutes
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 having surgery that would involve prepping the arm into the sterile field.
- •Patients with chronic kidney disease (eGFR <60).
研究组 & 干预措施
AMG
Experimental
The anesthesia team will manage the level of block based on AMG values
干预措施: AMG device (Device)
EMG
Active Comparator
The anesthesia team will manage the level of block based on EMG values
干预措施: EMG (Device)
结局指标
主要结局
Cumulative rocuronium dose
时间窗: Perioperative/Periprocedural
Weight- and time-adjusted mean cumulative rocuronium dose between the AMG and EMG groups
次要结局
- Mean sugammadex dose(Perioperative/Periprocedural)
- Number of rocuronium administrations(Perioperative/Periprocedural)
- Frequency of placing a peripheral nerve stimulator(Perioperative/Periprocedural)
- Depth of neuromuscular block prior to sugammadex administration(Perioperative/Periprocedural)
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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