Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-21 @ 6:31 PM
Study NCT ID:
NCT01992692
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2013-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remifentanil Requirement in Patients Receiving Surgical Treatment of 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': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-19', 'studyFirstSubmitDate': '2013-11-19', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentrations required to inhibit response to trachea intubation and skin incision', 'timeFrame': 'Anesthesia induction to 5min after skin incision'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'remifentanil', 'deep brain stimulator', 'cardiovascular response'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '26368663', 'type': 'DERIVED', 'citation': "Wang JF, Xu XP, Yu XY, Li JB, Wu X, Chen JC, Hu XW, Deng XM. Remifentanil Requirement for Inhibiting Responses to Tracheal Intubation and Skin Incision Is Reduced in Patients With Parkinson's Disease Undergoing Deep Brain Stimulator Implantation. J Neurosurg Anesthesiol. 2016 Oct;28(4):303-8. doi: 10.1097/ANA.0000000000000229."}]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement\n* Adult non-Parkinsonian patients undergoing intracranial surgery\n\nExclusion Criteria:\n\n* ASA score higher than Class II\n* predicted difficult airway\n* alcohol or drug abuser\n* informed consent was not provided'}, 'identificationModule': {'nctId': 'NCT01992692', 'briefTitle': "Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'orgStudyIdInfo': {'id': 'Parkinson-remifentanil'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PD group', 'description': 'Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement'}, {'label': 'non-PD group', 'description': 'Non-Parkinsonian patients 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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Jia-feng Wang', 'investigatorAffiliation': 'Changhai Hospital'}}}}