About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Known allergy to rocuronium
Neuromuscular disease that may interfere with neuromuscular data
Indication for rapid sequence induction
Prone position
Trial design
Parallel
Treatments tested in this trial
Acceleromyography (AMG)
Other interventionPhilips IntelliVue NMT Module
Electromyography (EMG)
Other interventionSenzime TetraGraph
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
TOFC=0
Time to TOF-Count=0
TOFR ≥ 0.90
Time to TOFR ≥ 0.90
Other outcomes
TOFC=2
Time to TOF-Count =2
Control TOF
Control TOF ratio (baseline) before administration of rocuronium
First PTC
Time to reappearance of the first response of PTC (PTC=1)
First TOF=1
Time to reappearance of the first response to TOF (TOFC=1)
Sponsors and contacts
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Matias Vested
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution