Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 7:02 PM
Study NCT ID:
NCT01072435
Status:
COMPLETED
Last Update Posted:
2020-12-07
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sedation degrees', 'timeFrame': 'One day'}, {'measure': "patient's and endoscopist´s satisfaction,", 'timeFrame': 'One day'}, {'measure': 'propofol consumption', 'timeFrame': 'One day'}, {'measure': 'vital signs:oxygen saturation,blood pressure,heart rate,breathing rate', 'timeFrame': 'One day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ERCP', 'patient-controlled sedation', 'target-controlled infusion', 'propofol', 'Sedation with propofol for ERCP', 'Endoscopic Retrograde Cholangiopancreatography'], 'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'Propofol is a drug of choice for deep sedation in endoscopy. Propofol can be administered in many ways: by infusion or intravenous boluses and with self-administration device (patient-controlled sedation; PCS). It is not clear which method of propofol administration would be preferable. The main objective of the trial is to compare 2 different methods of propofol administration during ERCP: patient-controlled administration(PCS) and target-controlled infusion (TCI).', 'detailedDescription': '80 patients of age 18-75 undergoing elective ERCP will be included to the randomized non-commercial clinical trial. Exclusion criteria are: allergy to the opioids or propofol, dementia, mental retardation, severe liver or kidney insufficiency, significant heart failure or lung disease, drug addiction. The endpoints are: ease of procedures performance, complications, degree of sedation, recovery time, propofol and opioid consumption. During the procedure patients observed and treated by the anaesthesiologist and anaesthesia nurse .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective ERCP patients\n\nExclusion Criteria:\n\n* allergy to propofol or opioid;\n* inability to cooperate;\n* ASA(American Society of Anaesthesiology)class greater than 3'}, 'identificationModule': {'nctId': 'NCT01072435', 'briefTitle': 'Target-controlled Infusion Versus Patient-controlled Sedation With Propofol in Endoscopic Retrograde Cholangiopancreatography (ERCP)', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Target-controlled Infusion vs Patient-controlled Sedation With Propofol in ERCP. A Randomized Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'a005c'}, 'secondaryIdInfos': [{'id': '2009-015564-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'patient-controlled sedation', 'description': 'PCS', 'interventionNames': ['Device: Patient-controlled sedation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'target-controlled infusion', 'description': 'TCI', 'interventionNames': ['Device: Target-controlled infusion']}], 'interventions': [{'name': 'Patient-controlled sedation', 'type': 'DEVICE', 'otherNames': ['Arcomed/Syramed AG infusion pump designed for self administration of medicines'], 'description': 'Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.', 'armGroupLabels': ['patient-controlled sedation']}, {'name': 'Target-controlled infusion', 'type': 'DEVICE', 'otherNames': ['Arcomed/Syramed AG target-controlled infusion device.'], 'description': 'Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol', 'armGroupLabels': ['target-controlled infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'Uusimaa', 'country': 'Finland', 'facility': 'Helsiki University central Hospital,Meilahti Hospital,Endoscopy unit', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Maxim Mazanikov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsiki University Central Hospital,Department of Anaesthesiology'}, {'name': 'Marianne Udd, MD.,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital,Department of Surgery'}, {'name': 'Leena Kylänpää, Docent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital,Department of Surgery'}, {'name': 'Outi Lindström, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital,Department of Surgery'}, {'name': 'Jorma Halttunen, Docent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital,Department of Surgery'}, {'name': 'Martti Färkilä, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital,Department of Gastroenterology'}, {'name': 'Reino Pöyhiä, Docent', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital,Department of Anaesthesiology'}, {'name': 'Harri Mustonen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal and General Surgery, Helsinki University Central Hospital,Helsinki,Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Maxim Mazanikov', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}