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临床试验/NCT04048655
NCT04048655进行中(未招募)不适用

Reversal of Neuromuscular Blockade During the General Anaesthesia

Tampere University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年4月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
Incidence of postrecovery relaxation

研究概览

简要总结

There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients starts to relax spontaneously again after the tof ratio has already recovered to the safe level (>90%).

The mechanism behind this in not well understood, and the incidence of the phenomenon is unclear. In this study the investigators try to determine the incidence of the aforementioned postrecovery relaxation.

详细描述

There are individual reports indicating that after the reversal of nondepolarizing neuromuscular blockade with neostigmine, some patients start to relax spontaneously again after the tof ratio has already recovered to the safe level (90%). The mechanism behind this in not well understood and the incidence of the phenomenon is unclear.

The aim of this study is to monitor the reversal of rocuronium induced neuromuscular blockade with neostigmine. The neuromuscular blockade is monitored with train of four stimulations using electromyography. After the reversal agent is given and train of four ratio has recovered to the level of 90%, the neuromuscular blockade is monitored another 30min to see if tof ratio starts to spontaneously fall again under the 90%. If aforementioned postrecovery relaxation happens, the investigators are able to calculate the incidence of the phenomenon.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery requiring general anaesthesia
  • Surgery is assumed to last more than 45 minutes
  • Body mass index less than 35kg/ m²

排除标准

  • Disease of central nervous system
  • Trauma of central nervous system
  • Disease affecting peripheral nervous system
  • Medication affecting peripheral nervous system

研究组 & 干预措施

Study group

Other

Single arm and everyone gets the same treatment according the protocol

干预措施: Neostigmine, Combinations (Drug)

结局指标

主要结局

Incidence of postrecovery relaxation

时间窗: 30 minutes

Number of patients (if any) with postrecovery relaxation divided by a number of all patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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