Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02555605
Status:
COMPLETED
Last Update Posted:
2015-09-21
First Post:
2015-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Sedation in Children With Respiratory Morbidities
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the occurrence of successful sedation', 'timeFrame': '1 hour', 'description': 'completion of imaging without requirement for rescheduling or general anaesthesia, and in the absence of adverse respiratory events such as apnoea, cough, oxygen desaturation, and bronchospasm or unplanned escalation of care (e.g. transfer from ward to paediatric intensive care unit or prolonged hospitalization).'}], 'secondaryOutcomes': [{'measure': 'the presence of bradycardia', 'timeFrame': '4 hours', 'description': 'Based on age-adjusted criteria, bradycardia was defined as a HR \\<20% below the lower limit of the normal ranges expressed in beats/min'}, {'measure': 'the presence of hypertension', 'timeFrame': '4 hours', 'description': 'Based on age-adjusted criteria hypertension was defined as a MAP \\>20% above the upper limit of the normal ranges expressed in mmHg'}, {'measure': 'the presence of nausea and vomiting.', 'timeFrame': '4 hours', 'description': 'defined as the occurrence of nausea and vomitting, expressed in "yes" or "no"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children', 'dexmedetomidine', 'magnetic resonance imaging scans', 'deep sedation', 'adverse respiratory events'], 'conditions': ['Respiratory Morbidity']}, 'referencesModule': {'references': [{'pmid': '26940080', 'type': 'DERIVED', 'citation': 'Najafi N, Veyckemans F, Van de Velde A, Poelaert J. Usability of dexmedetomidine for deep sedation in infants and small children with respiratory morbidities. Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. doi: 10.1111/aas.12715. Epub 2016 Mar 4.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the feasibility of dexmedetomidine in children with respiratory morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.', 'detailedDescription': 'Electronic medical records of children with at least 3 characteristics of respiratory morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of 5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse events experienced and sedation characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events and they were eligible for participation in this evaluation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children up to the age of 16 years with at least 3 characteristics of respiratory morbidities\n\nExclusion Criteria:\n\n* Children who had an American Society of Anaesthesiologists (ASA) physical status classification IV\n* Documented pre-existing cardiac conduction abnormalities\n* Renal impairment'}, 'identificationModule': {'nctId': 'NCT02555605', 'briefTitle': 'Dexmedetomidine Sedation in Children With Respiratory Morbidities', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Feasibility of Dexmedetomidine in Children With Respiratory Morbidities Undergoing Deep Sedation for Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': 'DEXMRI20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dexdor'], 'description': 'Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Nadia Najafi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Jan Poelaert, PhD MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Data Nurse', 'investigatorFullName': 'Veerle Van Mossevelde', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}