Comparison of Two Neuromuscular Transmission Monitors Based on Acceleromyography: TOF-Watch SX® and TOFScan®
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
研究概览
简要总结
The purpose is to evaluate the reproducibility of neuromuscular monitoring data of recovery from neuromuscular blockade, obtained with TOFScan® and TOF-Watch SX®, in adult and pediatric population.
Secondary purposes are to evaluate the reproducibility of data obtained with 2 monitors for:
- the onset of clinical action of curare: suppression of the first response of train of four monitoring (T1) of 95% initial value
- the duration of clinical action of curare: recovery of the first response of train of four monitoring (T1) to 25% initial value
- recovery of first (T1), second (T2), third (T3) and fourth response (T4) of train of four monitoring, and recovery of T4/T1 to 40% and 60% initial value (T4/T1 0.4 and 0.6)
- complete recovery from curarisation, at T4/T1=90% and T4/T1=100%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population:
- •Non opposition to research
- •> 18 years old
- •ASA score 1-3
- •Undergoing surgery with curarisation through tracheal intubation
- •Affiliation to social security
- •Pediatric population:
- •> 1 year old
- •Non opposition to research of child (if able to consent) or representatives with parental authority
- •ASA score 1-4
- •Undergoing surgery with curarisation
- •Affiliation to social security
排除标准
- •Adult population:
- •Allergy to administered drugs
- •Known or suspected difficult intubation
- •Pregnant women
- •BMI > 40
- •Pediatric population:
- •Allergy to administered drugs
- •Known or suspected difficult intubation
研究组 & 干预措施
Adult population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
干预措施: Rocuronium (Drug)
Adult population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
干预措施: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® (Device)
Adult population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
干预措施: Rocuronium (Drug)
Adult population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
干预措施: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® (Device)
Pediatric population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
干预措施: Rocuronium (Drug)
Pediatric population 1
TOF-Watch SX® on nondominant arm and TOFScan® on dominant arm
干预措施: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® (Device)
Pediatric population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
干预措施: Rocuronium (Drug)
Pediatric population 2
TOF-Watch SX® on dominant arm and TOFScan® on nondominant arm
干预措施: Neuromuscular monitoring with TOFScan® and TOF-Watch SX® (Device)
结局指标
主要结局
Time of recovery of the first (T1) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of the second (T2) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of the third (T3) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of the fourth (T4) response of train of four monitoring displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 40% of initial value displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 60% of initial value displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 90% of initial value displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
Time of recovery of T4/T1 of train of four monitoring at 100% of initial value displayed on TOFScan and on TOF Watch SX
时间窗: day 0, after induction of anesthesia
次要结局
- Time of suppression of the first response of train of four monitoring (T1) at 95% initial value displayed on TOFScan and on TOF Watch SX(day 0, after induction of anesthesia)
- Time of recovery of the first response of train of four monitoring (T1) to 25% initial value displayed on TOFScan and on TOF Watch SX(day 0, after induction of anesthesia)