Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-30 @ 5:56 PM
Study NCT ID:
NCT01355432
Status:
COMPLETED
Last Update Posted:
2012-05-02
First Post:
2011-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Rate Changes With Propofol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-01', 'studyFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in heart rate', 'timeFrame': 'Baseline & every 30 secs for 3 mins'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Patients']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study to quantify the changes in heart rate when propofol is administered after inhalational anesthesia induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Surgery patients at Nationwide Children's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 1 year of age or older.\n2. Routine (elective) surgical patients with ASA classifications of 1 or 2 (healthy).\n3. Patients that are already scheduled to receive inhalational induction followed by IV propofol.\n\nExclusion Criteria:\n\n1\\. Premature infants of less than 30 weeks, who are less that 60 weeks post-gestational age at the time of study.'}, 'identificationModule': {'nctId': 'NCT01355432', 'briefTitle': 'Heart Rate Changes With Propofol', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Changes in Heart Rate Following Administration of Propofol After Inhalational Induction', 'orgStudyIdInfo': {'id': 'IRB11-00236'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Propofol', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'There is no intervention, this is an observational study.', 'armGroupLabels': ['Propofol']}]}, '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': 'Christopher Lancaster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthesiologist', 'investigatorFullName': 'Christopher Lancaster', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}