Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT04071834
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2019-08-26', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood orphanin concentration', 'timeFrame': '24 hours', 'description': 'Concentration of blood orphanin in patients before and after anesthesia'}, {'measure': 'Blood norepinephrine concentration', 'timeFrame': '24 hours', 'description': 'Concentration of blood norepinephrine in patients before and after anesthesia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraspinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the Influence of Intraspinal anesthesia to the concentrations of blood orphanin, norepinephrine in patients with diabetes mellitus. We hope to explain the relationship between sensory and sympathetic nerves in diabetic patients undergoing intraspinal anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lower limb surgery under spinal anesthesia\n\nExclusion Criteria:\n\n* Emergency surgery\n* The operation time is more than 3 hours\n* Combined general anesthesia or nerve block anesthesia'}, 'identificationModule': {'nctId': 'NCT04071834', 'briefTitle': 'Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Second Hospital of Shanxi Medical University'}, 'officialTitle': 'Effect of Subarachnoid Anesthesia on Blood Orphanin and Norepinephrine in Diabetic Patients', 'orgStudyIdInfo': {'id': 'hanyi20190826'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diabetes mellitus group', 'description': 'Diabetic patients undergoing spinal anesthesia for lower extremity surgery', 'interventionNames': ['Diagnostic Test: ELISA']}, {'label': 'Non-diabetic group', 'description': 'Non-diabetic patients undergoing spinal anesthesia for lower extremity surgery', 'interventionNames': ['Diagnostic Test: ELISA']}], 'interventions': [{'name': 'ELISA', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of blood orphanin and norepinephrine in patients', 'armGroupLabels': ['Diabetes mellitus group', 'Non-diabetic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Second of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Hospital of Shanxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Zheng Guo', 'investigatorAffiliation': 'Second Hospital of Shanxi Medical University'}}}}