Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-03-14 @ 8:38 AM
Study NCT ID:
NCT02394002
Status:
UNKNOWN
Last Update Posted:
2015-03-20
First Post:
2015-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SEP Changes During Deep Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SEP ampiltude in burst-suppression-EEG', 'timeFrame': '2 hours'}]}, 'conditionsModule': {'keywords': ['EEG, burst-suppression, N20, SEP, median nerve, facilitation'], 'conditions': ['Somatosensory Evoked Potentials, and Electroencephalography']}, 'descriptionModule': {'briefSummary': 'The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied.\n\n60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia\n* Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation)\n\nExclusion Criteria:\n\n* periodical consumption of drugs and pharmaceuticals which influence cortical excitability\n* intraoperative contraindication for required depth of anaesthesia\n* neurological pre-existing illness\n* advanced hepatic insufficiency'}, 'identificationModule': {'nctId': 'NCT02394002', 'acronym': 'SEPinBSP', 'briefTitle': 'SEP Changes During Deep Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'The Effect of Burst-suppression-pattern in EEG on Generating Somatosensory Evoked Potentials', 'orgStudyIdInfo': {'id': '2013071151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain surgery', 'description': 'Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography', 'interventionNames': ['Drug: Propofol']}, {'type': 'EXPERIMENTAL', 'label': 'Spine surgery', 'description': 'Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General surgery', 'description': 'Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography', 'interventionNames': ['Drug: Propofol']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'armGroupLabels': ['Brain surgery', 'General surgery', 'Spine surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andrea Szelényi, Prof.', 'role': 'CONTACT', 'email': 'andrea.szelenyi@uni-duesseldorf.de', 'phone': '+49 211 8117646'}, {'name': 'Sebastian Braun, Dr.', 'role': 'CONTACT', 'email': 'sebastian.braun@med.uni-duesseldorf.de', 'phone': '+49 211 8107425'}, {'name': 'Gerhard Schneider, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurosurgical Clinic', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'centralContacts': [{'name': 'Andrea Szelényi, Prof.', 'role': 'CONTACT', 'email': 'andrea.szelenyi@uni-duesseldorf.de', 'phone': '+49 211 8117646'}], 'overallOfficials': [{'name': 'Andrea Szelényi, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurosurgical Clinic, Heinrich Heine University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrea Szelenyi', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Anaesthesiology, Heinrich Heine University', 'class': 'UNKNOWN'}, {'name': 'Department of Anesthesiology, Helios Klinikukm Wuppertal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Andrea Szelényi', 'investigatorFullName': 'Andrea Szelenyi', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}