Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-11 @ 8:47 PM
Study NCT ID:
NCT03234660
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2017-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-29', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-28', 'lastUpdatePostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glial fibrillary acid protein', 'timeFrame': 'change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction', 'description': 'plasma was collected at the given specific time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine']}, 'descriptionModule': {'briefSummary': 'Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.', 'detailedDescription': 'GFAP measure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children undergoing general anesthesia longer than 3 hours\n\nExclusion Criteria:\n\n* past history of anesthesia\n* cardiopulmonary bypass\n* preexisting neurocognitive dysfunction\n* abnormalities of liver profile (aspartate transaminase \\> 40 unit/L, alanine aminotransferase \\> 40 unit/L)'}, 'identificationModule': {'nctId': 'NCT03234660', 'briefTitle': 'Dexmedetomidine and Neuroprotection in Children Undergoing General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein', 'orgStudyIdInfo': {'id': 'H1706-132-861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'dexmedetomidine infusion', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'placebo infusion', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'description': 'dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'control', 'type': 'OTHER', 'description': '0.9% normal saline continuous infusion', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15710', 'city': 'Seoul', 'state': 'Jongro Gu', 'country': 'South Korea', 'facility': 'SNUH', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hee-Soo Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}