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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409260
• Other study ID #: EMG vs AMG
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: Matias Vested
• Phone: +4535455747
• Email: matias.vested[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Other:
• Acceleromyography (AMG)
Philips IntelliVue NMT Module
• Electromyography (EMG)
Senzime TetraGraph

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Matias Vested

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TOFC=2	Time to TOF-Count =2	Within 2 Hours
Other	Control TOF	Control TOF ratio (baseline) before administration of rocuronium	Within 1 Hour
Other	First PTC	Time to reappearance of the first response of PTC (PTC=1)	Within 1 Hour
Other	First TOF=1	Time to reappearance of the first response to TOF (TOFC=1)	Within 1 Hour
Other	Final TOFR	Final TOF ratio (defined as the TOF ratio upon conclusion of anesthesia)	Within 12 hours
Other	Difference between control and final TOFR	Difference between control and final TOF ratio	Within 12 Hours
Other	AMG-TOF ratio when EMG-TOFR = 0.90	AMG-TOF ratio when EMG-TOFR = 0.90	Within 12 Hours
Other	EMG-TOF ratio when AMG-TOFR = 0.90	EMG-TOF ratio when AMG-TOFR = 0.90	Within 12 Hours
Other	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
Other	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
Primary	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	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
Secondary	TOFC=0	Time to TOF-Count=0	Within 1 Hour
Secondary	TOFR = 0.90	Time to TOFR = 0.90	Within 4 Hours