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CompletedNCT06409260Updated Sep 15, 2026

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

An interventional study of Acceleromyography (AMG) and Electromyography (EMG) in Neuromuscular Blockade, sponsored by Matias Vested. Completed at 1 site in Denmark. Open to participants aged 6 Months to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Matias Vested · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
6 Months to 2 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Neuromuscular Blockade
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In context

Lead sponsor

Matias Vested is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
6 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Known allergy to rocuronium
  • Neuromuscular disease that may interfere with neuromuscular data
  • Indication for rapid sequence induction
  • Prone position
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Other
    N. tibialis

    Objective neuromuscular monitoring done on n. tibialis bilaterally

    Other: Acceleromyography (AMG) · Other: Electromyography (EMG)

  • Other
    N. ulnaris

    Objective neuromuscular monitoring done on n. ulnaris bilaterally

    Other: Acceleromyography (AMG) · Other: Electromyography (EMG)

Interventions

  • OtherAcceleromyography (AMG)

    Philips IntelliVue NMT Module

  • OtherElectromyography (EMG)

    Senzime TetraGraph

06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 Hours

Secondary outcomes

  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

    Time frame: Within 12 Hours

  2. TOFC=0

    Time to TOF-Count=0

    Time frame: Within 1 Hour

  3. TOFR ≥ 0.90

    Time to TOFR ≥ 0.90

    Time frame: Within 4 Hours

Other outcomes

  1. TOFC=2

    Time to TOF-Count =2

    Time frame: Within 2 Hours

  2. Control TOF

    Control TOF ratio (baseline) before administration of rocuronium

    Time frame: Within 1 Hour

  3. First PTC

    Time to reappearance of the first response of PTC (PTC=1)

    Time frame: Within 1 Hour

  4. First TOF=1

    Time to reappearance of the first response to TOF (TOFC=1)

    Time frame: Within 1 Hour

  5. Final TOFR

    Final TOF ratio (defined as the TOF ratio upon conclusion of anesthesia)

    Time frame: Within 12 hours

  6. Difference between control and final TOFR

    Difference between control and final TOF ratio

    Time frame: Within 12 Hours

  7. AMG-TOF ratio when EMG-TOFR ≥ 0.90

    AMG-TOF ratio when EMG-TOFR ≥ 0.90

    Time frame: Within 12 Hours

  8. EMG-TOF ratio when AMG-TOFR ≥ 0.90

    EMG-TOF ratio when AMG-TOFR ≥ 0.90

    Time frame: Within 12 Hours

  9. Number of artefacts

    Numbers of artefacts defined as appearance of ≥ one twitch with amplitude of ≥ 5% height in a period of ≥ 30 seconds with TOF 0

    Time frame: Within 12 Hours

  10. Residual neuromuscular blockade

    Signs and symptoms of residual neuromuscular blockade * dysphagia/ swallowing impairment assessed by observing difficulties swallowing (yes/no) or * upper airway obstruction * desaturation defined as more than 2 minutes with spO2 \< 93% * reintubation

    Time frame: Within 1 hour postoperatively

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Study locations

1 site
  • Rigshospitalet
    Copenhagen, 2100, Denmark
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References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06409260
Lead sponsor
Matias Vested
Responsible party
Matias Vested (Principal Investigator, Medical Doctor, PhD, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
May 10, 2024
Start date
Jul 1, 2024
Primary completion
Jun 17, 2025
Completion
Jun 17, 2025
Last update
Sep 15, 2026

Study contacts

Matias Vested
study chair · Rigshospitalet University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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