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

NCT06409260 | Recruiting

• 1 other identifier: EMG vs AMG
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade

Outcome Measures

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.

  12 Hours

Secondary Outcomes (3)

• Bland Altman analysis

  Within 12 Hours

• TOFC=0

  Within 1 Hour

• TOFR ≥ 0.90

  Within 4 Hours

Other Outcomes (10)

• TOFC=2

  Within 2 Hours

• Control TOF

  Within 1 Hour

• First PTC

  Within 1 Hour

Study Arms (2)

N. tibialis

OTHER

Objective neuromuscular monitoring done on n. tibialis bilaterally

Other: Acceleromyography (AMG); Other: Electromyography (EMG)

N. ulnaris

OTHER

Objective neuromuscular monitoring done on n. ulnaris bilaterally

Other: Acceleromyography (AMG); Other: Electromyography (EMG)

Interventions

Acceleromyography (AMG) OTHER

Philips IntelliVue NMT Module

N. tibialis; N. ulnaris

Electromyography (EMG) OTHER

Senzime TetraGraph

N. tibialis; N. ulnaris

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to rocuronium
• Neuromuscular disease that may interfere with neuromuscular data
• Indication for rapid sequence induction
• Prone position

Sponsors & Collaborators

• Matias Vested: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Neurofeedback

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Matias Vested

  Rigshospitalet University of Copenhagen

  STUDY CHAIR

Central Study Contacts

Matias Vested

CONTACT

+4535455747; matias.vested@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, PhD

Model Details: Randomized study

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: July 1, 2024
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)