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NCT Number: NCT06409260

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

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.

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Key information

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Acceleromyography (AMG)

Other

Philips IntelliVue NMT Module

Electromyography (EMG)

Other

Senzime TetraGraph

Primary outcomes

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

    Time frame: 12 Hours

    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.

Secondary outcomes

  1. Bland Altman analysis

    Time frame: Within 12 Hours

    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

  2. TOFC=0

    Time frame: Within 1 Hour

    Time to TOF-Count=0

  3. TOFR ≥ 0.90

    Time frame: Within 4 Hours

    Time to TOFR ≥ 0.90

Other outcomes

  1. TOFC=2

    Time frame: Within 2 Hours

    Time to TOF-Count =2

  2. Control TOF

    Time frame: Within 1 Hour

    Control TOF ratio (baseline) before administration of rocuronium

  3. First PTC

    Time frame: Within 1 Hour

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

  4. First TOF=1

    Time frame: Within 1 Hour

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

  5. Final TOFR

    Time frame: Within 12 hours

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

  6. Difference between control and final TOFR

    Time frame: Within 12 Hours

    Difference between control and final TOF ratio

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

    Time frame: Within 12 Hours

    AMG-TOF ratio when EMG-TOFR ≥ 0.90

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

    Time frame: Within 12 Hours

    EMG-TOF ratio when AMG-TOFR ≥ 0.90

  9. Number of artefacts

    Time frame: Within 12 Hours

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

  10. Residual neuromuscular blockade

    Time frame: Within 1 hour postoperatively

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Vested

CONTACT

[email protected]

+4535455747

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 10, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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