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临床试验/NCT02552875
NCT02552875已完成4 期

Shortening of the Twitch Stabilization Period by Tetanic Stimulation in Acceleromyography in Children and Young Adults

University of Regensburg2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
80
试验地点
2
主要终点
T1% measurement

研究概览

简要总结

Repetitive nerve stimulation is used to monitor the neuromuscular transmission function in infants, children and adults after the application of muscle relaxants. During repetitive stimulation of a motor nerve, amplitude of contractions of the corresponding muscle will increase to a plateau (twitch potentiation), which is known as the staircase phenomenon.

There is no systematic information about the staircase phenomenon of the adductor pollices muscle (ulnar nerve) in children between 1 month and 18 years .

In adults , a 50-Hz tetanus administered before initial twitch stabilization is able to shorten the twitch stabilization period and to eliminate this staircase phenomenon.

The purpose of this study is to investigate the characteristics of twitch potentiation in children between 1 month and 18 years by using acceleromyography.

In addition we investigate whether application of a 50-Hz tetanic stimulation is able to eliminate the twitch potentiation like in adults.

详细描述

  1. Background:

Acceleromyography at the adductor pollices muscle (ulnar nerve stimulation) is used to monitor the neuromuscular transmission function in infants, children and adults after the application of muscle relaxants. During repetitive stimulation of a motor nerve, amplitude of contractions of the corresponding muscle will increase to a plateau (twitch potentiation), which is known as the staircase phenomenon. This effect may influence the onset time and duration of twitch depression after the application of muscle relaxants. The staircase effect during the baseline stabilization period presents in a shorter time course and at lower degrees in smaller infants. In older infants, staircase effect presents in a longer period and is able to influence duration of twitch depression after the administration of muscle relaxants.

There is no information about the staircase phenomenon at the adductor pollices muscle (ulnar nerve stimulation) in children between 1 month and 21 years.

In adults , a 50-Hz tetanus administered before initial twitch stabilization is able to shorten the twitch stabilization period and to eliminate this phenomenon. 2. Aim of the study:

The purpose of this controlled, randomised, pragmatic study is to investigate the characteristics of twitch potentiation (T1%, first twitch of TOF-stimulation; TOFR, Train-of-Four-ratio) in children between 1 month and 21 years by using acceleromyography. In addition we stimulate the right and the left arm simultaneously with acceleromyography (TOF-stimulation). At the one hand a 50 Hz tetanus will be administered before twitch stabilization (TOF-stimulation). At the other hand TOF-stimulation for twitch stabilization will be started without tetanic stimulation 3. Methods:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
1 Month 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • general anesthesia

排除标准

  • participation in another trial
  • refusal of participation
  • state after burns
  • diabetes mellitus
  • reflux disease
  • difficult airway
  • pregnancy
  • Medications:
  • volatile anesthetics
  • antibiotics (Aminoglykoside, Polymyxin, Clindamycin, Lincomycin, Tetrazykline)
  • local anesthetics
  • magnesium
  • Ca-chanel-blockers
  • furosemid
  • theophyllin
  • phenytoin
  • cyclophosphamide
  • metoclopramide
  • β-blockers

结局指标

主要结局

T1% measurement

时间窗: 30 minutes

T1% increase dependent on stimulation with and without a 50 Hz tetanic stimulation

次要结局

  • TOFR% maesurement(30 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Unterbuchner

Dr. med. Christoph Unterbuchner, DESA

University of Regensburg

研究点 (2)

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