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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-2
SponsorMatias Vested

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Acceleromyography (AMG)

    Other intervention

    Philips IntelliVue NMT Module

  • Electromyography (EMG)

    Other intervention

    Senzime TetraGraph

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: N. tibialisOther 2 interventions
Group B: N. ulnarisOther 2 interventions

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matias Vested

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution