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

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ClinicalTrials.gov Identifier: NCT02552875
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Christoph Unterbuchner, University of Regensburg

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.


Condition or disease Intervention/treatment Phase
Train-of-Four-Monitoring Other: Tetanic stimulation Other: Staircase Stimulation Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Shortening of the Twitch Stabilization Period by Tetanic Stimulation in Acceleromyography in Children and Young Adults
Study Start Date : September 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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




Primary Outcome Measures :
  1. T1% measurement [ Time Frame: 30 minutes ]
    T1% increase dependent on stimulation with and without a 50 Hz tetanic stimulation


Secondary Outcome Measures :
  1. TOFR% maesurement [ Time Frame: 30 minutes ]
    TOFR%course dependent on stimulation with and without a 50 Hz tetanic stimulation



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Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552875


Locations
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Germany
University Medical Center Regensburg, Department of Anaesthesiology
Regensburg, Germany, 93055
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Christoph Unterbuchner, MD University Medical Center Regensburg, Germany

Publications:

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Responsible Party: Christoph Unterbuchner, Dr. med. Christoph Unterbuchner, DESA, University of Regensburg
ClinicalTrials.gov Identifier: NCT02552875     History of Changes
Other Study ID Numbers: 14-101-0114
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by Christoph Unterbuchner, University of Regensburg:
Acceleromyography
staircase phenomenon
tetanic stimulation