Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-25 @ 3:39 PM
Study NCT ID:
NCT01998204
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-23', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-23', 'lastUpdatePostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consciousness status', 'timeFrame': 'Participants will be monitored during the period of propofol infusion, an expected average of less than 10 min', 'description': "Consciousness status is evaluated by the observer's assessment of alertness and sedation score (OAA/S)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'propofol', 'deep brain stimulator'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '26495319', 'type': 'DERIVED', 'citation': "Xu XP, Yu XY, Wu X, Hu XW, Chen JC, Li JB, Wang JF, Deng XM. Propofol requirement for induction of unconsciousness is reduced in patients with Parkinson's disease: a case control study. Biomed Res Int. 2015;2015:953729. doi: 10.1155/2015/953729. Epub 2015 Oct 1."}]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is the second most prevalent neurodegenerative disease. The investigators clinical experience showed a trend of delayed emergence among patients undergoing deep brain stimulator (DBS) implantation and pulse generator placement under general anesthesia. Abnormal pharmacodynamics might be present among these patients, which had never been investigated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Our study recruits patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia and non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement under general anesthesia\n* non-Parkinsonian patients without Parkinson's disease undergoing intracranial surgery under general anesthesia\n\nExclusion Criteria:\n\n* ASA score higher than Class III\n* predicted difficult airway\n* hearing impairment\n* inability to corporate with instruction\n* alcohol or drug abuser\n* patients refusing to provide informed consent"}, 'identificationModule': {'nctId': 'NCT01998204', 'briefTitle': "Requirement of Propofol for Induction of Unconsciousness in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'orgStudyIdInfo': {'id': 'Parkinson-propofol'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD group', 'description': "Patients with Parkinson's disease undergoing deep brain stimulator implantation and pulse generator placement"}, {'label': 'non-PD group', 'description': "Patients without Parkinson's disease undergoing intracranial surgery"}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Department of Anesthesiology, Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jia-feng Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Changhai Hospital, Second Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jia-feng Wang', 'investigatorAffiliation': 'Changhai Hospital'}}}}