Comparison of the ToFscan and TetraGraph During Recovery of Neuromuscular Function in the Post Anesthesia Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Mean Train-of-Four Ratios (TOFR's)
研究概览
简要总结
The aim of this investigation is to compare the performance of two quantitative monitors utilized on post-anesthesia recovering patients. The ToFscan (Draeger Medical Inc., Telford, PA) represents one of the few standalone acceleromyography (AMG)-based quantitative monitors available for routine clinical use in the United States. The TetraGraph (Senzime AB, Uppsala, Sweden) is a standalone electromyography (EMG)-based quantitative monitor that recently received Conformité Européene (CE) approval. While both of these quantitative monitors can be utilized to guide intraoperative NMBA re-dosing and confirm recovery, they provide their objective data via drastically different techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
排除标准
- •Patients with unilateral 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.
研究组 & 干预措施
ToFscan (TS)
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
干预措施: ToFscan (TS) (Device)
Tetragraph (TG)
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
干预措施: TetraGraph (TG) (Device)
Tetragraph (TG)
TetraGraph placed on dominant hand, ToFscan placed on non-dominant hand
干预措施: ToFscan (TS) (Device)
ToFscan (TS)
ToFscan placed on dominant hand, TetraGraph (TG) placed on non-dominant hand
干预措施: TetraGraph (TG) (Device)
结局指标
主要结局
Mean Train-of-Four Ratios (TOFR's)
时间窗: baseline, after 5 minutes, after + 10 minutes
Train-of-four ratios is the ratio of the fourth muscle response to the first one.
次要结局
未报告次要终点
研究者
J. Ross Renew, M.D.
Principal Investigator
Mayo Clinic