Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT00952458
Status:
COMPLETED
Last Update Posted:
2012-08-24
First Post:
2009-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-23', 'studyFirstSubmitDate': '2009-08-02', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary complications of sedation', 'timeFrame': '1-4 hours'}], 'secondaryOutcomes': [{'measure': 'Efficacy of sedation', 'timeFrame': '1-4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety', 'Midazolam and propofol sedation', 'ERCP', 'Bispectral Index monitoring'], 'conditions': ['Gastrointestinal Endoscopy', 'Sedation']}, 'referencesModule': {'references': [{'pmid': '19190608', 'type': 'BACKGROUND', 'citation': 'von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.'}]}, 'descriptionModule': {'briefSummary': "This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation\n\nExclusion Criteria:\n\n* Missing informed consent\n* ASA V\n* Preexisting neurological deficit\n* Known pregnancy\n* Hypotension (RRsys\\<90mmHg), bradycardia (HR\\<50/min), hypoxia (SaO2\\<90%)'}, 'identificationModule': {'nctId': 'NCT00952458', 'acronym': 'EndoBISs', 'briefTitle': 'Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography', 'orgStudyIdInfo': {'id': '2094/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIS monitoring', 'description': 'Dosing of sedatives with BIS monitoring', 'interventionNames': ['Device: BIS monitoring']}, {'type': 'NO_INTERVENTION', 'label': 'Standard monitoring', 'description': 'Dosing of sedatives without BIS monitoring'}], 'interventions': [{'name': 'BIS monitoring', 'type': 'DEVICE', 'description': 'Neuromonitoring of depth of sedation with Bispectral Index', 'armGroupLabels': ['BIS monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Stefan von Delius, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum rechts der Isar der Technischen Universität München'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'II. Medizinische Klinik, Dr. Stefan von Delius', 'oldOrganization': 'Klinikum rechts der Isar der Technischen Universität München'}}}}