Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT05529420
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2022-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009123', 'term': 'Muscle Hypotonia'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age-based TOF 1 recovery', 'timeFrame': 'intraoperatively', 'description': 'Comparison of duration of clinical action after single-dose rocuronium to TOF 1 in different pediatric age groups'}], 'secondaryOutcomes': [{'measure': 'TOF 1 recovery', 'timeFrame': 'Intraoperatively', 'description': 'Comparison of duration of clinical action after single-dose rocuronium to TOF 1 relative to patient weight, gender, and height'}, {'measure': 'Muscle relaxation recovery time characteristics', 'timeFrame': 'Intraoperatively', 'description': 'Comparison of interval from single-dose rocuronium to TOF 2, 3, and 4 in different pediatric age groups and relative to patient weight, gender, and height'}, {'measure': 'Time to full muscle relaxation recovery', 'timeFrame': 'Intraoperatively', 'description': 'Comparison of interval from single-dose rocuronium to full recovery in different pediatric age groups and relative to patient weight, gender, and height'}, {'measure': 'Muscle relaxation reversal', 'timeFrame': 'Intraoperatively', 'description': 'Identification of a patient subgroup requiring antagonization after a surgical procedure'}, {'measure': 'Postoperative complications', 'timeFrame': '24 hours postoperatively', 'description': 'Monitoring of postoperative complications of general anesthesia'}, {'measure': 'Impact of sevoflurane anesthesia on the pharmacodynamics of rocuronium', 'timeFrame': 'intraoperatively', 'description': 'Influence of sevoflurane concentration on rocuronium pharmacodynamics'}, {'measure': 'Impact of body temperature on pharmacodynamics of rocuronium', 'timeFrame': 'intraoperatively', 'description': 'Influence of temperature on rocuronium pharmacodynamics'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['duration', 'muscle relaxant', 'rocuronium'], 'conditions': ['Muscle Relaxation']}, 'descriptionModule': {'briefSummary': 'Muscle relaxants represent an important part of general anesthesia in adult and pediatric patients. Their role is to facilitate intubation and enable some surgical interventions.\n\nAt our workplace, monitoring of the depth of neuromuscular blockade is a standard procedure in accordance with the 2017 recommendation of ČSARIM entitled "Principles of Patient Safety in Anesthesiology" \\[1,2\\]. At present, we mainly use rocuronium. One of the advantages of this non-depolarizing steroidal muscle relaxant with a rapid onset and intermediate duration of action is the existence of the specific antagonist sugammadex.', 'detailedDescription': 'Given the observational study design, we expect that no informed consent will be required. In pediatric patients undergoing a planned general anesthesia with non-depolarizing muscle relaxants, induction of anesthesia will involve either standard intravenous (an opioid, anesthetic, muscle relaxant) or inhalational agents according to the preference of the anesthesiologist. Standard monitoring during general anesthesia will be carried out including measurement of the depth of neuromuscular blockade (Train of Four, TOF, Avance CS2 machine, relaxometry module, stimulating current of 50 mA) every minute and body temperature monitoring. Subsequently, these parameters including the age-related minimum alveolar concentration of sevoflurane will be documented in the Case Report Form (CRF).\n\nRocuronium will be administered at a dose according to the Summary of Product Characteristics (SPC) and local expertise. Patient demographic parameters, dose of rocuronium, time of its administration, and time of TOF 1 measurement (= clinical effect, stimulation of the ulnar nerve - adductor pollicis muscle tension) will be documented in the CRF and if there is no need to add further doses of the muscle relaxant, TOF 2, TOF 3, TOF 4, and TOF-R ≥ 0,9 (= time to full recovery from the effect of the non-depolarizing muscle relaxant) will also be registered. In addition, reversal of neuromuscular blockade if applicable and the Aldrete score in the first and fifth minute after extubation will be recorded.\n\nIn patients monitored after an intervention in a recovery room, possible complications occurring within at least 30 minutes postoperatively will be documented (desaturation, the need for oxygen therapy, tachycardia \\>150 beats per minute, bradycardia \\<50 beats per minute, aspiration, sore throat, cough, hoarseness). All patients will be screened for aspiration pneumonia on chest X-ray within the first 24 hours after an intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients aged 0 to 18 years admitted for a planned intervention in general anesthesia with orotracheal or nasotracheal intubation and use of the muscle relaxant rocuronium', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients aged 0 to 18 years admitted for a planned intervention in general anesthesia with orotracheal or nasotracheal intubation and use of the muscle relaxant rocuronium\n* ASA score 1 or 2\n\nExclusion Criteria:\n\n* Patients requiring more types of muscle relaxants during general anesthesia induction\n* Patients requiring a rapid sequence induction to general anesthesia\n* Neuromuscular disease\n* Concomitant medication interfering with the metabolism of muscle relaxants (anticonvulsants, aminoglycosides, polypeptide antibiotics)\n* Comorbidities - renal or hepatic disorders\n* ASA ≥ 3'}, 'identificationModule': {'nctId': 'NCT05529420', 'acronym': 'DurAct', 'briefTitle': 'Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Brno University Hospital'}, 'officialTitle': 'Interindividual Variability in Duration of Action of Rocuronium in Pediatric Patients: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'KDAR FN Brno DurAct'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric patients rocuronium', 'description': 'In pediatric patients undergoing a planned general anesthesia with non-depolarizing muscle relaxants, induction of anesthesia will involve either standard intravenous (an opioid, anesthetic, muscle relaxant) or inhalational agents according to the preference of the anesthesiologist.', 'interventionNames': ['Other: measurement of the depth of neuromuscular blockade']}], 'interventions': [{'name': 'measurement of the depth of neuromuscular blockade', 'type': 'OTHER', 'otherNames': ['neuromuscular blockade depth'], 'description': 'time of TOF 1 measurement (= clinical effect, stimulation of the ulnar nerve - adductor pollicis muscle tension) will be documented in the CRF and if there is no need to add further doses of the muscle relaxant, TOF 2, TOF 3, TOF 4, and TOF-R ≥ 0,9 (= time to full recovery from the effect of the non-depolarizing muscle relaxant) will also be registered.', 'armGroupLabels': ['Pediatric patients rocuronium']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Brno University Hospital', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Petr Stourac, prof. MD., Ph.D., MBA', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of paediatric anaesthesia and intensive care medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brno University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Petr Štourač, MD', 'investigatorAffiliation': 'Brno University Hospital'}}}}