Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-04-14 @ 11:43 PM
Study NCT ID:
NCT02454868
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2015-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077208', 'term': 'Remifentanil'}], 'ancestors': [{'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate', 'timeFrame': 'intraoperative', 'description': 'Intubation is adequate if patient does not cough, does not try to breathe, vocal cords do not move, patient does not react and laringoscopy is Cormack class I or II'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Remifentanil', 'Intubation', 'Children'], 'conditions': ['Underdosing of Unspecified General Anesthetics']}, 'referencesModule': {'references': [{'pmid': '29728755', 'type': 'DERIVED', 'citation': 'Ono AH, Moura TR, Goveia CS, Guimaraes GMN, de Araujo Ladeira LC, da Silva HBG. ED50 of remifentanil for providing excellent intubating conditions when co-administered with a single standard dose of propofol without the use of muscle relaxants in children: dose-finding clinical trial. J Anesth. 2018 Aug;32(4):493-498. doi: 10.1007/s00540-018-2502-z. Epub 2018 May 4.'}]}, 'descriptionModule': {'briefSummary': "Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies.", 'detailedDescription': "Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown.\n\nMethod: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic Cormack grade I or II."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I or II\n* Scheduled for surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Predicted difficult airway\n* Severe neurologic or cardiologic conditions\n* Recent upper airway infectious diseases'}, 'identificationModule': {'nctId': 'NCT02454868', 'briefTitle': 'Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade', 'orgStudyIdInfo': {'id': 'UBrasilia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm', 'description': "There is a single study arm. Remifentanil will be infused before intubation. The first patient will receive remifentanil 2mg/kg. If a success occurs the next patient's dose will be decreased by 0.25mg/kg and else it will be increased by 0.25mg/kg. This rule will apply recursively as Dixon's Up-And-Down Method.", 'interventionNames': ['Drug: Remifentanil']}], 'interventions': [{'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva'], 'description': 'Remifentanil for intubation without neuromuscular blockade', 'armGroupLabels': ['Study arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catia S Goveia, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Brasilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Brasilia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}}