Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-01 @ 4:41 AM
Study NCT ID:
NCT00221260
Status:
COMPLETED
Last Update Posted:
2008-09-25
First Post:
2005-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Epidural Trial (POET) Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000758', 'term': 'Anesthesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-24', 'studyFirstSubmitDate': '2005-09-18', 'studyFirstSubmitQcDate': '2005-09-18', 'lastUpdatePostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure'}], 'secondaryOutcomes': [{'measure': 'DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension'}]}, 'conditionsModule': {'keywords': ['Analgesia', 'anesthesia'], 'conditions': ['Post Operative Pain Control']}, 'referencesModule': {'references': [{'pmid': '19247497', 'type': 'DERIVED', 'citation': 'Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study. PLoS One. 2009;4(2):e4644. doi: 10.1371/journal.pone.0004644. Epub 2009 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects at high risk of cardio-respiratory complications post operatively.\n\nExclusion Criteria:\n\nContraindication to epidural anesthesia'}, 'identificationModule': {'nctId': 'NCT00221260', 'briefTitle': 'Perioperative Epidural Trial (POET) Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Perioperative Epidural Trial (POET) Pilot Study', 'orgStudyIdInfo': {'id': 'C04-0078'}, 'secondaryIdInfos': [{'id': '04-3046'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'anesthesia', 'type': 'PROCEDURE', 'description': 'Intraoperative general anesthesia AND postoperative IV narcotic analgesia.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1L8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital, Clinical Health Research Unit', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Peter Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Dr. Peter Choi', 'oldOrganization': 'University of British Columbia'}}}}