Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-02 @ 6:49 AM
Study NCT ID:
NCT04603469
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2020-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypotension in Children With Down Syndrome With Anesthesia Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001794', 'term': 'Blood Pressure'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of non-invasive blood pressure during induction', 'timeFrame': '5 minutes', 'description': 'non invasive blood pressure during induction (systolic, diastolic and Mean pressures)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension on Induction']}, 'descriptionModule': {'briefSummary': 'Children generally undergo induction of anesthesia by inhalation of sevoflurane. Children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.', 'detailedDescription': 'Children generally undergo induction of anesthesia by inhalation of sevoflurane. This is particularly relevant for children with developmental delays as to avoid placement of an IV while awake. However, children with Down Syndrome experience bradycardia with induction of anesthesia using sevoflurane. It is unknown if this bradycardia is isolate or results in hypotension, thus requiring treatment. Isolate bradycardia without hypotension does not require treatment and should be avoided as many of these patients have underlying cardiac anomalies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Week', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is an observational study of children with down syndrome undergoing induction of general anesthesia with sevoflurane. vital signs of blood pressure, heart rate and pulse oximetry will be recorded on the anesthesia record as standard practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren \\<18 years old Requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3\n\nExclusion Criteria:\n\nPatients \\>18 years of age Patients without down syndrome Cyanotic congenital heart disease Use of antihypertensive medications Pulmonary hypertension patients undergoing intravenous induction of anesthesia ASA physical classification other than 1-3 emergency procedure'}, 'identificationModule': {'nctId': 'NCT04603469', 'briefTitle': 'Hypotension in Children With Down Syndrome With Anesthesia Induction', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Incidence of Hypotension in Children With Down Syndrome During Induction of Anesthesia With Sevoflurane', 'orgStudyIdInfo': {'id': 'H-48044'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trisomy 21 patients', 'description': 'Children \\<18 years old requiring general anesthesia with inhalation induction Down syndrome ASA physical classification 1-3', 'interventionNames': ['Other: Non invasive blood pressure']}], 'interventions': [{'name': 'Non invasive blood pressure', 'type': 'OTHER', 'otherNames': ['blood pressure'], 'description': 'measurement of blood pressure during induction of general anesthesia', 'armGroupLabels': ['Trisomy 21 patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Childrens Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Adam Adler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Adam Adler MD, MS, FAAP', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}