Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-08 @ 8:39 AM
Study NCT ID:
NCT03368833
Status:
TERMINATED
Last Update Posted:
2023-02-23
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caudal Blockade and Electrocardiographic Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Caudal blockade no longer being used in the ORs at this hospital.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in T wave amplitude', 'timeFrame': 'Baseline to 60 mins. post caudal', 'description': 'Change in T wave amplitude on the ECG tracings'}, {'measure': 'Change in T wave width', 'timeFrame': 'Baseline to 60 mins. post caudal', 'description': 'Change in T wave width on the ECG tracings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia Morbidity']}, 'descriptionModule': {'briefSummary': "Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Pediatric patients having general surgery at Nationwide Children's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA grade 1 or 2\n* Receiving general anesthesia with a caudal block\n\nExclusion Criteria:\n\n* Preexisting cardiac comorbidities'}, 'identificationModule': {'nctId': 'NCT03368833', 'briefTitle': 'Caudal Blockade and Electrocardiographic Changes', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Caudal Blockade and Electrocardiographic Changes', 'orgStudyIdInfo': {'id': 'IRB17-00861'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caudal block', 'description': 'Patients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care.', 'interventionNames': ['Diagnostic Test: Electrocardiogram']}, {'label': 'Control', 'description': 'Patients who do not receive a caudal block.', 'interventionNames': ['Diagnostic Test: Electrocardiogram']}], 'interventions': [{'name': 'Electrocardiogram', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ECG', 'EKG'], 'description': '12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.', 'armGroupLabels': ['Caudal block', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Senthil Krishna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Senthil G. Krishna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthesiologist', 'investigatorFullName': 'Senthil G. Krishna', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}