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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N. tibialis | Other | Objective neuromuscular monitoring done on n. tibialis bilaterally |
|
| N. ulnaris | Other | Objective neuromuscular monitoring done on n. ulnaris bilaterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceleromyography (AMG) | Other | Philips IntelliVue NMT Module |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matias Vested | Contact | +4535455747 | matias.vested@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Matias Vested | Rigshospitalet University of Copenhagen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42153960 | Derived | Wadland SS, Madsen KPD, Jensen MH, Hovind MF, Sonne M, Bottger M, Afshari A, Mondrup F, Vested M. Neuromuscular Monitoring of Rocuronium 0.6 mg/kg in Children Aged 3-24 Months With Electromyography and Acceleromyography: An Observational Study. Paediatr Anaesth. 2026 May 19. doi: 10.1002/pan.70220. Online ahead of print. |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Randomized study
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| Electromyography (EMG) |
| Other |
Senzime TetraGraph |
|
Time to TOF-Count=0
| Within 1 Hour |
| TOFR ≥ 0.90 | Time to TOFR ≥ 0.90 | Within 4 Hours |
| 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
| Within 1 hour postoperatively |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |