Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409260
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Neuromuscular Monitoring in Children 6 Months - 2 Years With Electromyography and Acceleromyography
Sponsor:
Matias Vested
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Objective Neuromuscular Monitoring in Children 6 Months - 2 Years With Electromyography and Acceleromyography A Randomized Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 yearsThe monitoring will be done bilaterally either on nulnaris 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
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 015 mgkg 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 09 among 8 of the included patients after administration of a single bolus of 01 mgkg 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
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 015 mgkg 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 09 among 8 of the included patients after administration of a single bolus of 01 mgkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None