Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT00559260
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010092', 'term': 'Oximetry'}, {'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'lastUpdateSubmitDate': '2008-09-12', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2008-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Sedation for Non-Emergent Upper and/or Lower Endoscopy']}, 'descriptionModule': {'briefSummary': 'This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:adult\n\n* (\\>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy\n\nExclusion Criteria:\n\n* Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis)\n* Baseline respiratory rate of \\< 6 breaths per minute\n* Baseline hypotension (systolic blood pressure \\< 90 mm Hg)\n* Baseline arterial oxygen saturation \\< 90% on room air\n* Baseline bradycardia: heart rate \\< 50 beats per minute\n* Baseline tachycardia: heart rate \\> 110 beats per minute\n* Allergy or inability to tolerate any of the sedatives or analgesics to be administered during the procedure\n* Inability to squeeze the Automated Responsiveness Test hand piece (last 50 subjects only)\n* Significant hearing impairment\n* Actively abusing alcohol, opioids, benzodiazapines or sedatives, or other drugs\n* Are considered tolerant to opioids, benzodiazapines and/or other sedatives through prescription.'}, 'identificationModule': {'nctId': 'NCT00559260', 'briefTitle': 'Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon Endo-Surgery'}, 'officialTitle': 'Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices While Being Passively Monitored', 'orgStudyIdInfo': {'id': 'CI-02-0004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Passive monitoring with pulse-oximetry, NIBP and ECG', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Foundation for Digestive Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Philip Miner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma Foundation for Digestive Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}}}}