Train-of-Four-MonitoringPhase 4STSTSNCT02552875
Shortening of the Twitch Stabilization Period by Tetanic Stimulation in Acceleromyography in Children and Young Adults
A Phase 4 study testing Tetanic stimulation and Staircase Stimulation in people with Train-of-Four-Monitoring, run by University of Regensburg at 1 site in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 1 month to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Train-of-Four-Monitoring
- What is being tested?
- Tetanic stimulation and Staircase Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- general anesthesia
Who cannot join
- participation in another trial
- refusal of participation
- state after burns
- diabetes mellitus
- reflux disease
- difficult airway
Show all 20Show fewer
- pregnancy
- Medications:
- volatile anesthetics
- antibiotics (Aminoglykoside, Polymyxin, Clindamycin, Lincomycin, Tetrazykline)
- local anesthetics
- magnesium
- Litium
- Ca-chanel-blockers
- furosemid
- theophyllin
- phenytoin
- cyclophosphamide
- metoclopramide
- β-blockers
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Regensburg, Department of Anaesthesiology
Regensburg, 93055
About this study
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 .
Read more
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
- 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.
- 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
- 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.
- 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.
- 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
- Train-of-Four-Monitoring
- Being tested
- Tetanic stimulation, Staircase Stimulation
- Keywords
- Acceleromyography, staircase phenomenon, tetanic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanic stimulationOther
50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon
Staircase StimulationOther
TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon
| Study group | Role | What they receive |
|---|---|---|
| Tetanic Stimulation | Active comparator | 50 Hz tetanic stimulation for 5 seconds before TOF-twitch stabilization at the one arm Receives: Other: Tetanic stimulation |
| Staircase Stimulation | Active comparator | TOF-twitch stabilisation without 50 Hz tetanic stimulation at the contralateral arm Receives: Other: Staircase Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
T1% measurement
T1% increase dependent on stimulation with and without a 50 Hz tetanic stimulation
Measured: 30 minutes
Secondary outcomes (1)
TOFR% maesurement
TOFR%course dependent on stimulation with and without a 50 Hz tetanic stimulation
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Train-of-Four-MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Unterbuchner, University of Regensburg
- Investigators
- Christoph Unterbuchner, MD, Principal investigator, University Medical Center Regensburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552875
- Sponsor's protocol ID
- 14-101-0114
- Acronym
- STSTS
- Status last verified
- Sep 2015
- First submitted
- 29 Jul 2014
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 15078372Berg 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 9366929Lee 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 9009939Zhou 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 23072260Kopman 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 11506113Driessen 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 15816566Goudsouzian NG, Standaert FG. The infant and the myoneural junction. Anesth Analg. 1986 Nov;65(11):1208-17. No abstract available.
PubMed 3532867Fuchs-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 17635389Unterbuchner 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortening of the Twitch Stabilization Period by Tetanic Stimulation in Acceleromyography in Children and Young Adults
- ClinicalTrials.gov ID
- NCT02552875
- Acronym / sponsor ID
- STSTS / 14-101-0114
- Conditions
- Train-of-Four-Monitoring
- Keywords
- Acceleromyography, staircase phenomenon, tetanic stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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
- 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.
- 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.
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetanic Stimulation | Active comparator | Other: Tetanic stimulation50 Hz tetanic stimulation for 5 seconds before TOF-twitch stabilization at the one arm |
| Staircase Stimulation | Active comparator | Other: Staircase StimulationTOF-twitch stabilisation without 50 Hz tetanic stimulation at the contralateral arm |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- general anesthesia
Key exclusion criteria (20 listed)
- participation in another trial
- refusal of participation
- state after burns
- diabetes mellitus
- reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanic stimulation50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon | Other | Tetanic Stimulation |
| Staircase StimulationTOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon | Other | Staircase Stimulation |
Primary outcome
T1% measurement
Time frame: 30 minutes
T1% increase dependent on stimulation with and without a 50 Hz tetanic stimulation
1 secondary outcome
TOFR% maesurement
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2015.
- Background: PubMed 15078372Saldien 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.
- Background: PubMed 9366929Berg 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.
- Background: PubMed 9009939Lee 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.
- Background: PubMed 23072260Zhou 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.
- Background: PubMed 11506113Kopman 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.
- Background: PubMed 15816566Driessen 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.
- Background: PubMed 3532867Goudsouzian NG, Standaert FG. The infant and the myoneural junction. Anesth Analg. 1986 Nov;65(11):1208-17. No abstract available.
- Background: PubMed 17635389Fuchs-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.
- Derived from this study: PubMed 31786715Unterbuchner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Unterbuchner, MD principal investigator
University Medical Center Regensburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanic stimulation and Staircase Stimulation in people with Train-of-Four-Monitoring, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1% measurement (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02552875, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2015.