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

NCT02552875 | Completed Phase 4 DMC

• 1 other identifier: 14-101-0114
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Train-of-Four-Monitoring

Keywords

Acceleromyography; staircase phenomenon; tetanic stimulation

Outcome Measures

Primary Outcomes (1)

• T1% measurement

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

  30 minutes

Secondary Outcomes (1)

• TOFR% maesurement

  30 minutes

Study Arms (2)

Tetanic Stimulation

ACTIVE COMPARATOR

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

Other: Tetanic stimulation

Staircase Stimulation

ACTIVE COMPARATOR

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

Other: Staircase Stimulation

Interventions

Tetanic stimulation OTHER

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

Tetanic Stimulation

Staircase Stimulation OTHER

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

Staircase Stimulation

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

University Medical Center Regensburg, Department of Anaesthesiology

Regensburg, 93055, Germany

Location

Related Publications (9)

• 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.

  PMID: 15078372 BACKGROUND

• 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.

  PMID: 9366929 BACKGROUND

• 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.

  PMID: 9009939 BACKGROUND

• 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.

  PMID: 23072260 BACKGROUND

• 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.

  PMID: 11506113 BACKGROUND

• 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.

  PMID: 15816566 BACKGROUND

• Goudsouzian NG, Standaert FG. The infant and the myoneural junction. Anesth Analg. 1986 Nov;65(11):1208-17. No abstract available.

  PMID: 3532867 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• 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.

  PMID: 31786715 DERIVED

Study Officials

• Christoph Unterbuchner, MD

  University Medical Center Regensburg, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Christoph Unterbuchner, DESA

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: September 17, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

DE (1)