Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT02937506
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2016-10-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Satisfaction With Propofol for Out Patient Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apadmanabhan@mchs.com', 'phone': '614-234-1079', 'title': 'Anantha Padmanabhan, MD', 'organization': 'Mount Carmel Health System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Propofol', 'description': 'Patients in the treatment arm will be given propofol only when having a colonoscopy.\n\nPropofol: The intervention is to use propofol as anesthesia during a colonoscopy.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 7, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fentanyl Plus Midazolam Only', 'description': 'Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.\n\nFentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 17, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea/Emesis', 'notes': 'Nausea or vomiting up to 24 hours after colonoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numEvents': 300, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 300, 'numEvents': 300, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Propofol', 'description': 'Patients in the treatment arm will be given propofol only when having a colonoscopy.\n\nPropofol: The intervention is to use propofol as anesthesia during a colonoscopy.'}, {'id': 'OG001', 'title': 'Fentanyl Plus Midazolam Only', 'description': 'Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.\n\nFentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.'}], 'classes': [{'categories': [{'title': 'Very Satisfied', 'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}, {'title': 'Satisfied', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Neutral/Less than satisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patient satisfaction was assessed the day of the procedure.', 'description': 'Satisfaction assessed using self-developed questionnaire.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Same as enrolled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Propofol', 'description': 'Patients in the treatment arm will be given propofol only when having a colonoscopy.\n\nPropofol: The intervention is to use propofol as anesthesia during a colonoscopy.'}, {'id': 'FG001', 'title': 'Fentanyl Plus Midazolam Only', 'description': 'Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.\n\nFentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Propofol', 'description': 'Patients in the treatment arm will be given propofol only when having a colonoscopy.\n\nPropofol: The intervention is to use propofol as anesthesia during a colonoscopy.'}, {'id': 'BG001', 'title': 'Fentanyl Plus Midazolam Only', 'description': 'Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.\n\nFentanyl Plus Midazolam: The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '61.2', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The age of the participant in completed years.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients scheduled for an outpatient colonoscopy at a single ambulatory surgery center.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2016-10-17', 'resultsFirstSubmitDate': '2017-08-30', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-30', 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction', 'timeFrame': 'Patient satisfaction was assessed the day of the procedure.', 'description': 'Satisfaction assessed using self-developed questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['propofol', 'colonoscopy', 'patient satisfaction'], 'conditions': ['Colon Cancer', 'IBS', 'Polyps']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.', 'detailedDescription': 'Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed.\n\nPatients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients having an outpatient colonoscopy\n\nExclusion Criteria:\n\n\\- High risk patients (ASA IV \\& V) who are not candidates for colonoscopy in an outpatient center will be excluded.'}, 'identificationModule': {'nctId': 'NCT02937506', 'briefTitle': 'Patient Satisfaction With Propofol for Out Patient Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Mount Carmel Health System'}, 'officialTitle': 'Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study', 'orgStudyIdInfo': {'id': '131115-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propofol', 'description': 'Patients in the treatment arm will be given propofol only when having a colonoscopy.', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Fentanyl Plus Midazolam Only', 'description': 'Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.', 'interventionNames': ['Drug: Fentanyl Plus Midazolam']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Diprivan'], 'description': 'The intervention is to use propofol as anesthesia during a colonoscopy.', 'armGroupLabels': ['Propofol']}, {'name': 'Fentanyl Plus Midazolam', 'type': 'DRUG', 'otherNames': ['Sublimaze', 'Versed'], 'description': 'The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.', 'armGroupLabels': ['Fentanyl Plus Midazolam Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mount Carmel Health System', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Anantha Padmanabhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Carmel Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Carmel Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}