Clinical trial NCT06062290: Does Electromyography Improve Precision and Reliability of Neuromuscular Monitoring in Paediatric Patients
Official title: Original Title: Does ElecTromyography Improve preCision and Reliability of nEuromuscular moniToring in paEdiatRic pAtients - A Monocentric Randomized Prospective Agreement Study - ETCETERA
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuromuscular Blockade, Residual
Postoperative Complications
Keywords: Electromyography
Neuromuscular Blockade
Postoperative Complications
Lead sponsor: University Hospital Ulm
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The ETCETERA study will be performed in children \<5 years of age scheduled for elective, non-cardiac surgery requiring general anaesthesia and neuromuscular blockade.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Precision of TOF (train of four) measurements
timeFrame: intraoperatively
Secondary outcomes:
measure: Agreement of TOF values during spontaneous recovery of neuromuscular function
timeFrame: intraoperatively
Other outcomes:
measure: Tactile TOF-count measurement
timeFrame: intraoperatively
measure: Postoperative pulmonary events
timeFrame: on the day of surgery in the recovery room
measure: Skin lesions, redness and pressure points on the forearms
timeFrame: on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier
measure: Pain associated with the EMG and KMG measurement
timeFrame: on the day of surgery in the recovery room and at hospital discharge or on postoperative day 7, whichever occurs earlier
Locations:
city: Ulm
country: Germany
facility: University Hospital Ulm
state: Baden-Württemberg
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine, University of Ulm, Ulm, Germany.
name: Flora Scheffenbichler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buttner W, Finke W, Hilleke M, Reckert S, Vsianska L, Brambrink A. [Development of an observational scale for assessment of postoperative pain in infants]. Anasthesiol Intensivmed Notfallmed Schmerzther. 1998 Jun;33(6):353-61. doi: 10.1055/s-2007-994263. German.
citation: Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268.