Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-01 @ 9:59 AM
Study NCT ID:
NCT01091766
Status:
COMPLETED
Last Update Posted:
2012-07-24
First Post:
2010-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-23', 'studyFirstSubmitDate': '2010-03-22', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'T-wave elevation in the ECG after intravenous administration of the test solution', 'timeFrame': '2 minutes', 'description': '0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations of T-wave.'}], 'secondaryOutcomes': [{'measure': 'Alteration in heart rate caused by intravenous injection of the test solution', 'timeFrame': '2 minutes', 'description': '0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations in heart rate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['local anaesthetics toxicity', 'heart arrhythmia', 'heart rate', 'heart conduction', 'regional anaesthesia', 'paediatric anaesthesia', 'cardio-vascular system', 'prevention'], 'conditions': ['Anaesthesia', 'Toxicity']}, 'referencesModule': {'references': [{'pmid': '19915187', 'type': 'RESULT', 'citation': 'Mauch J, Kutter AP, Madjdpour C, Koepfer N, Frotzler A, Bettschart-Wolfensberger R, Weiss M. Electrocardiographic alterations during intravascular application of three different test doses of bupivacaine and epinephrine: experimental study in neonatal pigs. Br J Anaesth. 2010 Jan;104(1):94-7. doi: 10.1093/bja/aep313.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epinephrine in anaesthetised children up to 16 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0 to 16\n* healthy\n* parental consent\n\nExclusion Criteria:\n\n* ASA \\>1\n* allergy against local anaesthetics'}, 'identificationModule': {'nctId': 'NCT01091766', 'briefTitle': 'Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Sensitivity of Electrocardiogram on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine: a Study in Children of Different Age', 'orgStudyIdInfo': {'id': 'StV 25/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine', 'description': 'test solution consists of bupivacaine 0.125%', 'interventionNames': ['Drug: intravenous injection of test solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine+epinephrine', 'description': 'test solution consists of bupivacaine 0.125% with epinephrine 1:200000', 'interventionNames': ['Drug: intravenous injection of test solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epinephrine', 'description': 'test solution consists of epinephrine 1:200000', 'interventionNames': ['Drug: intravenous injection of test solution']}], 'interventions': [{'name': 'intravenous injection of test solution', 'type': 'DRUG', 'description': 'test dose consists of 0.2 ml/kg body weight test solution of the assigned drug', 'armGroupLabels': ['bupivacaine']}, {'name': 'intravenous injection of test solution', 'type': 'DRUG', 'description': 'test dose consists of 0.2 ml/kg body weight test solution of the assigned drug', 'armGroupLabels': ['bupivacaine+epinephrine']}, {'name': 'intravenous injection of test solution', 'type': 'DRUG', 'description': 'test dose consists of 0.2 ml/kg body weight test solution of the assigned drug', 'armGroupLabels': ['epinephrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital, Anesthesiology", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Markus Weiss, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Childrens Hospital Zurich, Anesthesiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital, Zurich", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}