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CompletedNCT02552875STSTSUpdated Sep 17, 2015

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

A Phase 4 interventional study of Tetanic stimulation and Staircase Stimulation in Train-of-Four-Monitoring, sponsored by University of Regensburg. Completed at 1 site in Germany. Open to participants aged 1 Month to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-17.

Sponsored by University of Regensburg · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Month to 21 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Train-of-Four-Monitoring

Keywords

  • Acceleromyography
  • staircase phenomenon
  • tetanic stimulation
03

In context

Lead sponsor

University of Regensburg is the lead sponsor of 67 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • general anesthesia

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Tetanic Stimulation

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

    Other: Tetanic stimulation

  • Active comparator
    Staircase Stimulation

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

    Other: Staircase Stimulation

Interventions

  • OtherTetanic stimulation

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

  • OtherStaircase Stimulation

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

06

What researchers measure

Primary outcomes

  1. T1% measurement

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

    Time frame: 30 minutes

Secondary outcomes

  1. TOFR% maesurement

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

    Time frame: 30 minutes

07

Study locations

1 site
  • University Medical Center Regensburg, Department of Anaesthesiology
    Regensburg, 93055, Germany
08

References and documents

Publications

  • Saldien V, Vermeyen KM. Neuromuscular transmission monitoring in children. Paediatr Anaesth. 2004 Apr;14(4):289-92. doi: 10.1046/j.1460-9592.2003.01152.x. No abstract available. PubMed 15078372 ↗
  • Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x. PubMed 9366929 ↗
  • Lee GC, Iyengar S, Szenohradszky J, Caldwell JE, Wright PM, Brown R, Lau M, Luks A, Fisher DM. Improving the design of muscle relaxant studies. Stabilization period and tetanic recruitment. Anesthesiology. 1997 Jan;86(1):48-54. doi: 10.1097/00000542-199701000-00008. PubMed 9009939 ↗
  • Zhou ZJ, Wang X, Zheng S, Zhang XF. The characteristics of the staircase phenomenon during the period of twitch stabilization in infants in TOF mode. Paediatr Anaesth. 2013 Apr;23(4):322-7. doi: 10.1111/pan.12041. Epub 2012 Oct 17. PubMed 23072260 ↗
  • Kopman AF, Kumar S, Klewicka MM, Neuman GG. The staircase phenomenon: implications for monitoring of neuromuscular transmission. Anesthesiology. 2001 Aug;95(2):403-7. doi: 10.1097/00000542-200108000-00023. PubMed 11506113 ↗
  • Driessen JJ, Robertson EN, Booij LH. Acceleromyography in neonates and small infants: baseline calibration and recovery of the responses after neuromuscular blockade with rocuronium. Eur J Anaesthesiol. 2005 Jan;22(1):11-5. doi: 10.1017/s0265021505000037. PubMed 15816566 ↗
  • Goudsouzian NG, Standaert FG. The infant and the myoneural junction. Anesth Analg. 1986 Nov;65(11):1208-17. No abstract available. PubMed 3532867 ↗
  • Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x. PubMed 17635389 ↗
  • Unterbuchner C, Werkmann M, Ziegleder R, Kraus S, Seyfried T, Graf B, Zeman F, Blobner M, Sinner B, Metterlein T. Shortening of the twitch stabilization period by tetanic stimulation in acceleromyography in infants, children and young adults (STSTS-Study): a prospective randomised, controlled trial. J Clin Monit Comput. 2020 Dec;34(6):1343-1349. doi: 10.1007/s10877-019-00435-4. Epub 2019 Nov 30. PubMed 31786715 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02552875
Lead sponsor
University of Regensburg
Responsible party
Christoph Unterbuchner (Dr. med. Christoph Unterbuchner, DESA, University of Regensburg) — Principal investigator
First posted
Sep 17, 2015
Start date
Sep 2014
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Sep 17, 2015

Study contacts

Christoph Unterbuchner, MD
principal investigator · University Medical Center Regensburg, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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