Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 5:52 AM
Study NCT ID:
NCT06409260
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058765', 'term': 'Neurofeedback'}], 'ancestors': [{'id': 'D001676', 'term': 'Biofeedback, Psychology'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D030141', 'term': 'Feedback, Psychological'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'TOFC=2', 'timeFrame': 'Within 2 Hours', 'description': 'Time to TOF-Count =2'}, {'measure': 'Control TOF', 'timeFrame': 'Within 1 Hour', 'description': 'Control TOF ratio (baseline) before administration of rocuronium'}, {'measure': 'First PTC', 'timeFrame': 'Within 1 Hour', 'description': 'Time to reappearance of the first response of PTC (PTC=1)'}, {'measure': 'First TOF=1', 'timeFrame': 'Within 1 Hour', 'description': 'Time to reappearance of the first response to TOF (TOFC=1)'}, {'measure': 'Final TOFR', 'timeFrame': 'Within 12 hours', 'description': 'Final TOF ratio (defined as the TOF ratio upon conclusion of anesthesia)'}, {'measure': 'Difference between control and final TOFR', 'timeFrame': 'Within 12 Hours', 'description': 'Difference between control and final TOF ratio'}, {'measure': 'AMG-TOF ratio when EMG-TOFR ≥ 0.90', 'timeFrame': 'Within 12 Hours', 'description': 'AMG-TOF ratio when EMG-TOFR ≥ 0.90'}, {'measure': 'EMG-TOF ratio when AMG-TOFR ≥ 0.90', 'timeFrame': 'Within 12 Hours', 'description': 'EMG-TOF ratio when AMG-TOFR ≥ 0.90'}, {'measure': 'Number of artefacts', 'timeFrame': 'Within 12 Hours', 'description': 'Numbers of artefacts defined as appearance of ≥ one twitch with amplitude of ≥ 5% height in a period of ≥ 30 seconds with TOF 0'}, {'measure': 'Residual neuromuscular blockade', 'timeFrame': 'Within 1 hour postoperatively', 'description': 'Signs and symptoms of residual neuromuscular blockade\n\n* dysphagia/ swallowing impairment assessed by observing difficulties swallowing (yes/no) or\n* upper airway obstruction\n* desaturation defined as more than 2 minutes with spO2 \\< 93%\n* reintubation'}], 'primaryOutcomes': [{'measure': 'Time from injection of rocuronium until appearance of the first TOF ratio ≥ 90', 'timeFrame': '12 Hours', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Bland Altman analysis', 'timeFrame': 'Within 12 Hours', 'description': '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'}, {'measure': 'TOFC=0', 'timeFrame': 'Within 1 Hour', 'description': 'Time to TOF-Count=0'}, {'measure': 'TOFR ≥ 0.90', 'timeFrame': 'Within 4 Hours', 'description': 'Time to TOFR ≥ 0.90'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neuromuscular Blockade']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nNMBAs 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.\n\nIn 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.\n\nIt 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 6 months - 2 years of age\n* Scheduled for elective surgery under general anaesthesia with intubation and use of rocuronium\n* American Society of Anesthesiologists (ASA) physical status classification I to III\n\nExclusion Criteria:\n\n* Known allergy to rocuronium\n* Neuromuscular disease that may interfere with neuromuscular data\n* Indication for rapid sequence induction\n* Prone position'}, 'identificationModule': {'nctId': 'NCT06409260', 'briefTitle': 'Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Objective Neuromuscular Monitoring in Children (6 Months - 2 Years) With Electromyography and Acceleromyography: A Randomized Study', 'orgStudyIdInfo': {'id': 'EMG vs AMG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'N. tibialis', 'description': 'Objective neuromuscular monitoring done on n. tibialis bilaterally', 'interventionNames': ['Other: Acceleromyography (AMG)', 'Other: Electromyography (EMG)']}, {'type': 'OTHER', 'label': 'N. ulnaris', 'description': 'Objective neuromuscular monitoring done on n. ulnaris bilaterally', 'interventionNames': ['Other: Acceleromyography (AMG)', 'Other: Electromyography (EMG)']}], 'interventions': [{'name': 'Acceleromyography (AMG)', 'type': 'OTHER', 'description': 'Philips IntelliVue NMT Module', 'armGroupLabels': ['N. tibialis', 'N. ulnaris']}, {'name': 'Electromyography (EMG)', 'type': 'OTHER', 'description': 'Senzime TetraGraph', 'armGroupLabels': ['N. tibialis', 'N. ulnaris']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Matias Vested', 'role': 'CONTACT', 'email': 'matias.vested@regionh.dk', 'phone': '+4535455747'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Matias Vested', 'role': 'CONTACT', 'email': 'matias.vested@regionh.dk', 'phone': '+4535455747'}], 'overallOfficials': [{'name': 'Matias Vested', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matias Vested', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Medical Doctor, PhD', 'investigatorFullName': 'Matias Vested', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}