Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01411020
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2011-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-04', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dose of propofol', 'timeFrame': 'two days (duration of hospitalization)', 'description': 'to obtain a dose appropriate of propofol in induction of anesthesia'}]}, 'conditionsModule': {'conditions': ['Children Under General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '19496767', 'type': 'BACKGROUND', 'citation': 'Munoz HR, Leon PJ, Fuentes RS, Echevarria GC, Cortinez LI. Prospective evaluation of the time to peak effect of propofol to target the effect site in children. Acta Anaesthesiol Scand. 2009 Aug;53(7):883-90. doi: 10.1111/j.1399-6576.2009.01995.x. Epub 2009 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obtained informed consent\n* children between 3 and 11 years\n* healthy\n* elective surgery under general anesthesia\n* no premedication\n\nExclusion Criteria:\n\n* body mass index for age \\> 95th percentile\n* chronic or acute intake of any sedative drug\n* any known adverse effect to the study drugs'}, 'identificationModule': {'nctId': 'NCT01411020', 'briefTitle': 'Target-controlled Infusion of Propofol for Induction of Pediatric Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years', 'orgStudyIdInfo': {'id': 'Ricardo Fuentes'}, 'secondaryIdInfos': [{'id': 'Hernan Muñoz'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grupo 1', 'description': 'Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 2', 'description': 'Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 3', 'description': 'Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 4', 'description': 'Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 5', 'description': 'Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 6', 'description': 'Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 7', 'description': 'Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 8', 'description': 'Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 9', 'description': 'Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}, {'type': 'EXPERIMENTAL', 'label': 'Grupo 10', 'description': 'Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg', 'interventionNames': ['Procedure: endotracheal intubation']}], 'interventions': [{'name': 'endotracheal intubation', 'type': 'PROCEDURE', 'description': 'to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,', 'armGroupLabels': ['Grupo 1', 'Grupo 10', 'Grupo 2', 'Grupo 3', 'Grupo 4', 'Grupo 5', 'Grupo 6', 'Grupo 7', 'Grupo 8', 'Grupo 9']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Clinico Universidad Catolica', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor Asistente, Departamento de AnestesiologĂa', 'investigatorFullName': 'Ricardo Fuentes Henriquez', 'investigatorAffiliation': 'Pontificia Universidad Catolica de Chile'}}}}