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Clinical Trials/NCT02552875
NCT02552875CompletedPhase 4

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

University of Regensburg1 site in 1 country80 target enrollmentStarted: September 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
T1% measurement

Study Overview

Brief Summary

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.

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
1 Month to 21 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Tetanic Stimulation

Active Comparator

50 Hz tetanic stimulation for 5 seconds before TOF-twitch stabilization at the one arm

Intervention: Tetanic stimulation (Other)

Staircase Stimulation

Active Comparator

TOF-twitch stabilisation without 50 Hz tetanic stimulation at the contralateral arm

Intervention: Staircase Stimulation (Other)

Outcomes

Primary Outcomes

T1% measurement

Time Frame: 30 minutes

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

Secondary Outcomes

  • TOFR% maesurement(30 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christoph Unterbuchner

Dr. med. Christoph Unterbuchner, DESA

University of Regensburg

Study Sites (1)

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