Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients (ETCETERA)

University Hospital Ulm

Status: Active, not recruiting

Conditions: Postoperative Complications; Neuromuscular Blockade, Residual

Treatments: Device: Electromyography (EMG); Device: Kinemyography (KMG)

Study type: Observational

Funder types: Other

Identifiers

NCT06062290

ETCETERA

Details and patient eligibility

About

Neuromuscular monitoring is used as a standard surveillance method of neuromuscular function to ensure full recovery at the end of anaesthesia. The currently available devices properly provide respective information in adults but not in children. Furthermore, response to neuromuscular blocking agents differs between adults and children due to age-related differences in body composition, physiological function, and acetylcholine receptor density.

Recently, electromyographic (EMG) technologies to monitor neuromuscular function were increasingly developed including disposables for nerve stimulation and measurement of the compound muscle action potential in children. However, it is still unclear whether the precision and reliability of these devices is superior to the currently available neuromuscular monitoring for children based on kinemyography (KMG).

The ETCETERA study will test the hypothesis that neither EMG nor KMG provides inferior train-of-four readings to the respective reference method in infants and children below five years.

Full description

The ETCETERA trial is a randomized clinical agreement study which will prospectively enrol sixty-four children below five years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions.

The children's neuromuscular function is measured on one hand with EMG and on the other hand with KMG in a randomised fashion. Additionally, randomisation will be stratified upon age groups: 1) neonates: birth to <28 days, 2) infants 28 days to ≤3 months, 3) toddlers: >3 months to ≤2 years, 4) children >2 years to <5 years.

Based on the high failure rate of currently available neuromuscular monitoring devices in infants and neonates, in this randomised agreement study we will primarily compare precision and reliability of EMG and KMG-measured Train-of-Four (TOF) values during spontaneous recovery from a rocuronium-induced neuromuscular blockade in neonates, infants, toddlers, and children <5 years using the age-appropriate paediatric sensors.

Enrollment: 64 patients

Sex: All

Ages: 1 hour to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children and infants < 5 years
• non-cardiac surgery requiring general anaesthesia and neuromuscular blockade
• signed informed written consent
• American Society of Anesthesiologists physical status <4
• intraoperative positioning with access to both arms

Exclusion criteria

• allergy to neuromuscular blocking agents
• allergy to neuromuscular monitoring adhesive electrode
• neurologic disease
• surgical procedures outside the operating room
• children receiving neuromuscular blocking agents immediately before surgery

Trial design

64 participants in 4 patient groups

neonates

Description:

birth to \<28 days

Treatment:

Device: Kinemyography (KMG)

Device: Electromyography (EMG)

infants

Description:

28 days to ≤3 months

Treatment:

Device: Kinemyography (KMG)

Device: Electromyography (EMG)

toddlers

Description:

\>3 months to ≤2 years

Treatment:

Device: Kinemyography (KMG)

Device: Electromyography (EMG)

children

Description:

\>2 years to \<5 years

Treatment:

Device: Kinemyography (KMG)

Device: Electromyography (EMG)

Sponsor of this trial

Lead Sponsor

University Hospital Ulm