跳至主要内容
临床试验/NCT05231525
NCT05231525已完成不适用

Recovery Evaluation of Two Neuromuscular Blockade Monitoring Devices on Abductor Pollicis Muscle, the TOFScan and the Wireless WiTOF

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.

研究概览

简要总结

The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

详细描述

The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

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

入选标准

  • All programmed surgery with intraveinous injection of ATRACURIUM
  • American society of anesthesiology patient score of I, II or III
  • Patient being free of tutorship or curatorship
  • Acceptance of the patient after clear and loyal information

排除标准

  • Surgery without access simultaneously to the two arms
  • Emergency surgery
  • Rapid sequence induction
  • Usage of an other curare than ATRACURIUM
  • Contraindication on ATRACURIUM usage
  • Patient with pace maker
  • Patient with Arné score > or = to 11
  • Patient without social security coverage
  • Pregnant of breastfeeding women
  • Patient under social protection

结局指标

主要结局

Evaluate the neuromuscular blockade recovery after intraveinous injection of atracurium with 2 differents monitors.

时间窗: During the whole period of the surgical operation maximum 8 hours

Comparison on the obtention delay for the T4/T1 ratio superior ou equal to 90% beetween the WiTOF and the TOFScan

次要结局

  • Number and duration of perturbation from the surgical environnement that could limit the usage of a wireless monitor(During the whole period of the surgical operation maximum 8 hours)
  • Evaluate the performance of the monitors for the follow up of neuromuscular recovery(During the whole period of the surgical operation maximum 8 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验