Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-01-23 @ 9:13 PM
Study NCT ID:
NCT01747733
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Sedation During Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-30', 'releaseDate': '2021-04-06'}, {'resetDate': '2023-12-05', 'releaseDate': '2023-02-28'}], 'estimatedResultsFirstSubmitDate': '2021-04-06'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D056805', 'term': 'Consciousness Monitors'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2012-12-07', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of sedation', 'timeFrame': '1 day', 'description': "Sedation measured by Bispectral Index (BiS) compared with RASS (Richmond Agitation-Sedation Score), MOAA/S (Modified Observer's Assessment of Alertness/Sedation) and Ramsay sedation score"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endoscopy', 'ERCP', 'PCS', 'Sedation', 'Bispectral index'], 'conditions': ['Sedation']}, 'referencesModule': {'references': [{'pmid': '21295639', 'type': 'BACKGROUND', 'citation': 'Mazanikov M, Udd M, Kylanpaa L, Lindstrom O, Aho P, Halttunen J, Farkkila M, Poyhia R. Patient-controlled sedation with propofol and remifentanil for ERCP: a randomized, controlled study. Gastrointest Endosc. 2011 Feb;73(2):260-6. doi: 10.1016/j.gie.2010.10.005.'}]}, 'descriptionModule': {'briefSummary': 'Use of sedation is often required in endoscopic procedures such as ERCP (endoscopic retrograde cholangiopancreatography). However, assessment of the level of sedation during these procedures is not investigated in detail.\n\nThe purpose of this study is to compare different sedation scales and bispectral index during sedation in endoscopic procedures in order to find the best suited assessment method for sedation under these conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing endoscopic procedures requiring anaesthesist administered sedation in the endoscopy unit in HUCH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients undergoing endoscopic procedure in the endoscopy unit in HUCH\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01747733', 'briefTitle': 'Assessment of Sedation During Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Assessment of Sedation During Endoscopy, a Prospective Validation Study', 'orgStudyIdInfo': {'id': 'DNRO 336/13/03/02/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopy patients', 'description': 'Patients undergoing endoscopy in the endoscopy unit in HUCH (Helsinki University Central Hospital).', 'interventionNames': ['Device: Bispectral Index']}], 'interventions': [{'name': 'Bispectral Index', 'type': 'DEVICE', 'description': 'use of BiS-monitor in the assessment of the level of sedation in patients receiving sedation in endoscopy procedures when compared to clinical sedation scales, such as the Richmond agitation-sedation score.', 'armGroupLabels': ['Endoscopy patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': "Jarno Jokelainen', M.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jarno Jokelainen, MD', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-06', 'type': 'RELEASE'}, {'date': '2021-04-30', 'type': 'RESET'}, {'date': '2023-02-28', 'type': 'RELEASE'}, {'date': '2023-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jarno Jokelainen, MD, Principal Investigator, Helsinki University Central Hospital'}}}}