Shortening of the Twitch Stabilization Period by Tetanic Stimulation in Acceleromyography in Children and Young Adults
NCT ID: NCT02552875
Last Updated: 2015-09-17
Study Results
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Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2014-09-30
2015-09-30
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Tetanic Stimulation
50 Hz tetanic stimulation for 5 seconds before TOF-twitch stabilization at the one arm
Tetanic stimulation
50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon
Staircase Stimulation
TOF-twitch stabilisation without 50 Hz tetanic stimulation at the contralateral arm
Staircase Stimulation
TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon
Interventions
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Tetanic stimulation
50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon
Staircase Stimulation
TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Month
21 Years
ALL
Yes
Sponsors
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University of Regensburg
OTHER
Responsible Party
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Christoph Unterbuchner
Dr. med. Christoph Unterbuchner, DESA
Principal Investigators
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Christoph Unterbuchner, MD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Regensburg, Germany
Locations
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University Medical Center Regensburg, Department of Anaesthesiology
Regensburg, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
Goudsouzian NG, Standaert FG. The infant and the myoneural junction. Anesth Analg. 1986 Nov;65(11):1208-17. No abstract available.
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.
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.
Other Identifiers
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14-101-0114
Identifier Type: -
Identifier Source: org_study_id
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