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

September 16, 2015 updated by: Christoph Unterbuchner, University of Regensburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  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:

    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.

  4. 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.

  5. 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

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Regensburg, Germany, 93055
        • University medical center Regensburg, Department of anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tetanic Stimulation
50 Hz tetanic stimulation for 5 seconds before TOF-twitch stabilization at the one arm
Other: Tetanic stimulation
50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon
Active Comparator: Staircase Stimulation
TOF-twitch stabilisation without 50 Hz tetanic stimulation at the contralateral arm
Other: Staircase Stimulation
TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T1% measurement
Time Frame: 30 minutes
T1% increase dependent on stimulation with and without a 50 Hz tetanic stimulation
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOFR% maesurement
Time Frame: 30 minutes
TOFR%course dependent on stimulation with and without a 50 Hz tetanic stimulation
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Christoph Unterbuchner, MD, University Medical Center Regensburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

September 17, 2015

Last Update Submitted That Met QC Criteria

September 16, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-101-0114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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