Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recovered TOFr (%)
研究概览
简要总结
This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients requiring anesthetic care and use of neuromuscular blockade
- •Weight range of 20 - 60 kg
排除标准
- •Patients with history of a peripheral neurologic or neuropathic disorder
- •Patients in whom the upper extremity cannot be used for TOF monitoring
- •Patients undergoing a surgical procedure in which neuromuscular blockade is not required
- •Edematous patients
结局指标
主要结局
Recovered TOFr (%)
时间窗: At the end of surgery (maximum 7 hours from baseline)
Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.
Baseline TOFr (%)
时间窗: Immediately prior to start of surgery
Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.
次要结局
- Recovered Amplitude (mV)(At the end of surgery (maximum 7 hours from baseline))
- Rate of Muscle Recovery (Minutes)(At the end of surgery (maximum 7 hours from baseline))
- Baseline Amplitude (mV)(Immediately prior to start of surgery)
研究者
Joseph D. Tobias
Chairman, Dept. of Anesthesiology & Pain Medicine
Nationwide Children's Hospital