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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06409260
Enrollment
120
Registered
2024-05-10
Start date
2024-07-01
Completion date
2025-10-01
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Brief 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.

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.

Interventions

OTHERAcceleromyography (AMG)

Philips IntelliVue NMT Module

Senzime TetraGraph

Sponsors

Matias Vested
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized study

Eligibility

Sex/Gender
ALL
Age
6 Months to 2 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Time from injection of rocuronium until appearance of the first TOF ratio ≥ 9012 HoursDuration 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

MeasureTime frameDescription
Bland Altman analysisWithin 12 HoursAgreement 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
TOFC=0Within 1 HourTime to TOF-Count=0
TOFR ≥ 0.90Within 4 HoursTime to TOFR ≥ 0.90

Other

MeasureTime frameDescription
Final TOFRWithin 12 hoursFinal TOF ratio (defined as the TOF ratio upon conclusion of anesthesia)
Difference between control and final TOFRWithin 12 HoursDifference between control and final TOF ratio
AMG-TOF ratio when EMG-TOFR ≥ 0.90Within 12 HoursAMG-TOF ratio when EMG-TOFR ≥ 0.90
TOFC=2Within 2 HoursTime to TOF-Count =2
Number of artefactsWithin 12 HoursNumbers of artefacts defined as appearance of ≥ one twitch with amplitude of ≥ 5% height in a period of ≥ 30 seconds with TOF 0
Residual neuromuscular blockadeWithin 1 hour postoperativelySigns 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
EMG-TOF ratio when AMG-TOFR ≥ 0.90Within 12 HoursEMG-TOF ratio when AMG-TOFR ≥ 0.90
Control TOFWithin 1 HourControl TOF ratio (baseline) before administration of rocuronium
First PTCWithin 1 HourTime to reappearance of the first response of PTC (PTC=1)
First TOF=1Within 1 HourTime to reappearance of the first response to TOF (TOFC=1)

Countries

Denmark

Contacts

Primary ContactMatias Vested
matias.vested@regionh.dk+4535455747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026