Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceleromyography (AMG), Electromyography (EMG).
- Who it may be relevant to
- Registry conditions: Neuromuscular Blockade. Basic parameters: 6 months — 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Objective Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography: A Randomized Study
Overview
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
- Other Acceleromyography (AMG)
Philips IntelliVue NMT Module - Other Electromyography (EMG)
Senzime TetraGraph
Primary outcome measures
- Time from injection of rocuronium until appearance of the first TOF ratio ≥ 90 [Time frame: 12 Hours]
Secondary outcome measures (3)
- Bland Altman analysis [Time frame: Within 12 Hours]
- TOFC=0 [Time frame: Within 1 Hour]
- TOFR ≥ 0.90 [Time frame: Within 4 Hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
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. PMID 42153960
Identifiers
NCT: NCT06409260 · EMG vs AMG