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

Objective Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography: A Randomized Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Other: Acceleromyography (AMG); Other: Electromyography (EMG)

Detailed Description

Objective neuromuscular monitoring is strongly recommended when administering neuromuscular blocking agents (NMBA). However, objective neuromuscular monitoring may be challenging, especially in smaller children due to the limited size of their extremities which often are not easily accessible due to issues such as sterile draping and surgical equipment. Consequently, paediatric anaesthesia care providers often experience problems with neuromuscular monitoring.

NMBAs improve intubating conditions and prevent airway injury in children and infants (<12 months of age). However, both patient age and type of anaesthesia influence onset and duration of action. Infants have shorter onset time of NMBAs compared to older children, and a higher proportion of infants had excellent intubating conditions compared to older children at two minutes after a dose of 0.15 mg/kg cisatracurium. Inhalation anaesthetics prolong recovery from cisatracurium compared to total intravenous anaesthesia and a longer duration of action is seen in infants compared to older children. However, as compared to adults, less profound neuromuscular blockade may be sufficient in children to establish satisfactory intubating conditions.

In children < 3 years old, a study reported residual neuromuscular blockade (TOF (Train Of Four) ratio < 0.9) among 8% of the included patients after administration of a single bolus of 0.1 mg/kg cisatracurium, but the actual proportion may have been as high as 20%. To prevent residual neuromuscular block, objective neuromuscular monitoring is recommended. In adults residual neuromuscular block may result in respiratory events (hypoxaemia and airway obstruction), unpleasant symptoms of muscle weakness, prolonged post-anaesthesia care unit stay, and an increased risk of postoperative pulmonary complications.

It is possible to monitor onset time and duration of action of NMBAs with electromyography (EMG) or acceleromyography (AMG) by train-of-four (TOF) stimulation of a peripheral nerve. Typically, the ulnar nerve is stimulated. In smaller children the tibial nerve can be used as an alternative. However, a recent study in adults reports that there may be important differences when comparing EMG and AMG TOF monitoring at the ulnar nerve with EMG detecting recovery of neuromuscular function later than AMG. Only one study in infants has reported that monitoring of neuromuscular function with AMG applied on the first toe may be a suitable alternative when the thumb is inaccessible. One recent study has reported the feasibility of monitoring the depth of neuromuscular block in infants using electromyography. No study has to our knowledge compared AMG to EMG in infants and small children.

The investigators hypothesize that AMG will indicate faster recovery (time to return to TOF 90%) from neuromuscular block than EMG A secondary aim of this study is to investigate agreement between the two monitors using a Bland Altman analysis comparing onset time and recovery from deep to moderate rocuronium-induced neuromuscular block with EMG and AMG.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matias Vested; Phone Number: +4535455747; Email: matias.vested@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
    • Contact: Matias Vested; Phone Number: +4535455747; Email: matias.vested@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: N. tibialis; Objective neuromuscular monitoring done on n. tibialis bilaterally	Other: Acceleromyography (AMG); Philips IntelliVue NMT Module; Other: Electromyography (EMG); Senzime TetraGraph
Other: N. ulnaris; Objective neuromuscular monitoring done on n. ulnaris bilaterally	Other: Acceleromyography (AMG); Philips IntelliVue NMT Module; Other: Electromyography (EMG); Senzime TetraGraph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 12 Hours
TOFC=0	Time to TOF-Count=0	Within 1 Hour
TOFR ≥ 0.90	Time to TOFR ≥ 0.90	Within 4 Hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOFC=2	Time to TOF-Count =2	Within 2 Hours
Control TOF	Control TOF ratio (baseline) before administration of rocuronium	Within 1 Hour
First PTC	Time to reappearance of the first response of PTC (PTC=1)	Within 1 Hour
First TOF=1	Time to reappearance of the first response to TOF (TOFC=1)	Within 1 Hour
Final TOFR	Final TOF ratio (defined as the TOF ratio upon conclusion of anesthesia)	Within 12 hours
Difference between control and final TOFR	Difference between control and final TOF ratio	Within 12 Hours
AMG-TOF ratio when EMG-TOFR ≥ 0.90	AMG-TOF ratio when EMG-TOFR ≥ 0.90	Within 12 Hours
EMG-TOF ratio when AMG-TOFR ≥ 0.90	EMG-TOF ratio when AMG-TOFR ≥ 0.90	Within 12 Hours
Number of artefacts	Numbers of artefacts defined as appearance of ≥ one twitch with amplitude of ≥ 5% height in a period of ≥ 30 seconds with TOF 0	Within 12 Hours
Residual neuromuscular blockade	Signs and symptoms of residual neuromuscular blockade; dysphagia/ swallowing impairment assessed by observing difficulties swallowing (yes/no) or; upper airway obstruction; desaturation defined as more than 2 minutes with spO2 < 93%; reintubation	Within 1 hour postoperatively

Collaborators and Investigators

• Sponsor: Matias Vested
• Investigators: Study Chair: Matias Vested, Rigshospitalet University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EMG vs AMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No