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Completed

NCT Number: NCT02552875

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

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.

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Key information

Age range

1 month–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Regensburg, Department of Anaesthesiology

Regensburg, 93055, Germany

About this study

  • 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.

  • 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

  • Methods:

Anaesthesia will be induced and maintained without muscle relaxants by propofol and remifentanil. After this acceleromyography will be performed simultaneously at the right and the left arm (adductor pollices muscle, ulnar nerve). At the one hand a 50 Hz tetanus will be administered before twitch stabilization (TOF-stimulation). At the contralateral side TOF-stimulation for twitch stabilization will be started without tetanus. TOF measurements will be collected by 2 TOF Watch SX and two notebooks for the course of 30 minutes.

  • Inclusion criterions/ groups

-general anesthesia (total intravenous anaesthesia)

Groups (total amount= 80)

  • group A: 18-21 years; n= 10
  • group B: 12-18 years; n= 10
  • group C: 6-12 years; n= 10
  • group D: 3-6 years; n= 10
  • group E: 25-60 months; n= 10
  • group F: 12-24 months; n= 10
  • group G: 6-11 months; n= 10
  • group H: 1-5 months; n= 10.
  • Exclusion criterions
  • participation in another trial
  • refusal of participation
  • state after burns
  • diabetes mellitus
  • reflux disease
  • difficult airway
  • pregnancy

Medications:

  • volatile anesthetics
  • antibiotics (aminoglycosides, polymyxin, clindamycin, lincomycin, tetracyclines)
  • local anesthetics
  • magnesium
  • lithium
  • Ca-chanel-blockers
  • furosemide
  • theophylline
  • phenytoin
  • cyclophosphamide
  • metoclopramide
  • β-blockers

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • general anesthesia

Exclusion criteria

  • 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
  • Litium
  • Ca-chanel-blockers
  • furosemid
  • theophyllin
  • phenytoin
  • cyclophosphamide
  • metoclopramide
  • β-blockers

Treatment and study plan

Tetanic stimulation

Other

50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon

Staircase Stimulation

Other

TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon

Primary outcomes

  1. T1% measurement

    Time frame: 30 minutes

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

Secondary outcomes

  1. TOFR% maesurement

    Time frame: 30 minutes

    TOFR%course dependent on stimulation with and without a 50 Hz tetanic stimulation

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Acronym: STSTS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2015
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.