Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-28 @ 8:34 AM
Study NCT ID:
NCT01142635
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2010-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electromyographic (EMG) on the Anaesthesia Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-10', 'studyFirstSubmitDate': '2010-06-10', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The behaviour of biosignal on the anaesthesia monitor', 'timeFrame': '30 minutes', 'description': 'The visibility of elctromyogram and elctroencephalogram on the anaesthesia monitor'}], 'secondaryOutcomes': [{'measure': 'The behaviour of depth of anaesthesia indexes (BIS, SE, RE) during intubation', 'timeFrame': '30 min', 'description': 'Intubation-associated changes in the numerical values of BIS, SE, RE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Electroencephalogram', 'Electromyogram', 'Entropy Index', 'Bispectral Index', 'Neuromuscular blockade; rocuronium', 'Propofol', 'Intubation'], 'conditions': ['Anaesthesia']}, 'descriptionModule': {'briefSummary': 'Intubation may induce electromyographic (EMG) activity, causing depth of anaesthesia monitors to show misleadingly high values. The investigators want to investigate whether this EMG activity can be visually seen on the anaesthesia monitor.', 'detailedDescription': 'Patients are anaesthetized with target controlled infusion of propofol. To facilitate intubation, the patients are randomized to receive rocuronium either 0,6 mg/kg or 1,2 mg/kg. BIS, Entropy and the biosignal collected with the Entropy strip are collected on a computer. The visible biosignal on the anaesthesia monitor is recorded with a video camera. BIS, Entropy, biosignal and video clip of the anaesthesia monitor will be analyzed in detail.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females giving informed consent\n* age range 18-65 years\n* elective surgery: gynaecological\n* general anaesthesia\n* ASA classification 1 or 2\n\nExclusion Criteria:\n\n* pregnancy\n* body mass index \\> 30\n* disease affecting CNS\n* overuse of alcohol\n* drug abuse\n* unability to understand, read or use Finnish language'}, 'identificationModule': {'nctId': 'NCT01142635', 'briefTitle': 'Electromyographic (EMG) on the Anaesthesia Monitor', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'The Appearance of Electromyography on the Anaesthesia Monitor.', 'orgStudyIdInfo': {'id': 'R08197M'}, 'secondaryIdInfos': [{'id': '2008-008129-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Rocuronium bromide', 'type': 'DRUG', 'otherNames': ['Esmeron'], 'description': 'Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose'}, {'name': 'Rocuronium bromide', 'type': 'DRUG', 'otherNames': ['Esmeron.'], 'description': 'Rocuronium, iv, single dose, single bolus, 1.2 mg/kg'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Arvi Yli-Hankala, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Arvi Yli-Hankala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Arvi Yli-Hankala/Professor', 'oldOrganization': 'Tampere University Hospital'}}}}