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Neuromuscular BlockadeNCT06409260

Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography

A study testing Acceleromyography (AMG) and Electromyography (EMG) in people with Neuromuscular Blockade, run by Matias Vested at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare AMG and EMG (Philips IntelliVue NMT module and Senzime TetraGraph) in the objective monitoring of neuromuscular blocking in children between the age of 6 months and 2 years.The monitoring will be done bilaterally either on n.ulnaris or n. tibialis. Read more about this study

Who is it for?
Ages 6 months to 2 yearsHealthy volunteers can take part
Conditions the study is for
Neuromuscular Blockade
What is being tested?
Acceleromyography (AMG) and Electromyography (EMG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteDenmark
Study dates
1 Jul 2024to 17 Jun 2025
Phase
Interventional
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 6 months to 2 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients 6 months - 2 years of age
  • Scheduled for elective surgery under general anaesthesia with intubation and use of rocuronium
  • American Society of Anesthesiologists (ASA) physical status classification I to III

Who cannot join

  • Known allergy to rocuronium
  • Neuromuscular disease that may interfere with neuromuscular data
  • Indication for rapid sequence induction
  • Prone position

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Objective Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography: A Randomized Study

The aim of this study is to compare AMG and EMG (Philips IntelliVue NMT module and Senzime TetraGraph) in the objective monitoring of neuromuscular blocking in children between the age of 6 months and 2 years.The monitoring will be done bilaterally either on n.ulnaris or n. tibialis. The hypothesis of the study is that AMG will indicate faster recovery time (time to return to TOF 90%) from neuromuscular block than EMG.

Read the detailed description

Objective neuromuscular monitoring is strongly recommended when administering neuromuscular blocking agents (NMBA). However, objective neuromuscular monitoring may be challenging, especially in smaller children due to the limited size of their extremities which often are not easily accessible due to issues such as sterile draping and surgical equipment. Consequently, paediatric anaesthesia care providers often experience problems with neuromuscular monitoring.

NMBAs improve intubating conditions and prevent airway injury in children and infants (<12 months of age). However, both patient age and type of anaesthesia influence onset and duration of action. Infants have shorter onset time of NMBAs compared to older children, and a higher proportion of infants had excellent intubating conditions compared to older children at two minutes after a dose of 0.15 mg/kg cisatracurium. Inhalation anaesthetics prolong recovery from cisatracurium compared to total intravenous anaesthesia and a longer duration of action is seen in infants compared to older children. However, as compared to adults, less profound neuromuscular blockade may be sufficient in children to establish satisfactory intubating conditions.

In children < 3 years old, a study reported residual neuromuscular blockade (TOF (Train Of Four) ratio < 0.9) among 8% of the included patients after administration of a single bolus of 0.1 mg/kg cisatracurium, but the actual proportion may have been as high as 20%. To prevent residual neuromuscular block, objective neuromuscular monitoring is recommended. In adults residual neuromuscular block may result in respiratory events (hypoxaemia and airway obstruction), unpleasant symptoms of muscle weakness, prolonged post-anaesthesia care unit stay, and an increased risk of postoperative pulmonary complications.

It is possible to monitor onset time and duration of action of NMBAs with electromyography (EMG) or acceleromyography (AMG) by train-of-four (TOF) stimulation of a peripheral nerve. Typically, the ulnar nerve is stimulated. In smaller children the tibial nerve can be used as an alternative. However, a recent study in adults reports that there may be important differences when comparing EMG and AMG TOF monitoring at the ulnar nerve with EMG detecting recovery of neuromuscular function later than AMG. Only one study in infants has reported that monitoring of neuromuscular function with AMG applied on the first toe may be a suitable alternative when the thumb is inaccessible. One recent study has reported the feasibility of monitoring the depth of neuromuscular block in infants using electromyography. No study has to our knowledge compared AMG to EMG in infants and small children.

The investigators hypothesize that AMG will indicate faster recovery (time to return to TOF 90%) from neuromuscular block than EMG A secondary aim of this study is to investigate agreement between the two monitors using a Bland Altman analysis comparing onset time and recovery from deep to moderate rocuronium-induced neuromuscular block with EMG and AMG.

Being tested
Acceleromyography (AMG), Electromyography (EMG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acceleromyography (AMG)Other

    Philips IntelliVue NMT Module

  • Electromyography (EMG)Other

    Senzime TetraGraph

Study groups in NCT06409260
Study groupRoleWhat they receive
N. tibialisOtherObjective neuromuscular monitoring done on n. tibialis bilaterally
Receives: Other: Acceleromyography (AMG); Other: Electromyography (EMG)
N. ulnarisOtherObjective neuromuscular monitoring done on n. ulnaris bilaterally
Receives: Other: Acceleromyography (AMG); Other: Electromyography (EMG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from injection of rocuronium until appearance of the first TOF ratio ≥ 90

    Duration of action, defined as time from end of injection of rocuronium 0.6 mg/kg (2xED95) until appearance of the first TOF (Train Of Four) ratio ≥ 90% monitored at the tibial or ulnar nerve.

    Measured: 12 Hours

Secondary outcomes (3)
  1. Bland Altman analysis

    Agreement between the EMG and AMG monitors using a Bland Altman analysis comparing onset time and recovery from deep to moderate NMB with EMG and AMG

    Measured: Within 12 Hours

  2. TOFC=0

    Time to TOF-Count=0

    Measured: Within 1 Hour

  3. TOFR ≥ 0.90

    Time to TOFR ≥ 0.90

    Measured: Within 4 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2024
  2. Study start1 Jul 2024
  3. Primary completion17 Jun 2025
  4. Study completion17 Jun 2025

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized study
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06409260
Sponsor's protocol ID
EMG vs AMG
Status last verified
Sep 2026
First submitted
7 May 2024
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wadland SS, Madsen KPD, Jensen MH, Hovind MF, Sonne M, Bottger M, Afshari A, Mondrup F, Vested M. Neuromuscular Monitoring of Rocuronium 0.6 mg/kg in Children Aged 3-24 Months With Electromyography and Acceleromyography: An Observational Study. Paediatr Anaesth. 2026 May 19. doi: 10.1002/pan.70220. Online ahead of print.

    PubMed 42153960

Questions about this trial

What is this clinical trial studying?

A study testing Acceleromyography (AMG) and Electromyography (EMG) in people with Neuromuscular Blockade, run by Matias Vested at 1 site in Denmark.

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 3 inclusion and 4 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 15 Sep 2026. 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 Denmark. 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.

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?

Time from injection of rocuronium until appearance of the first TOF ratio ≥ 90 (time frame: 12 Hours). 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 NCT06409260, which also lists 1 linked publication.

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 15 Sep 2026.

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