Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2026-02-02 @ 5:11 PM
Study NCT ID:
NCT00974961
Status:
UNKNOWN
Last Update Posted:
2010-03-18
First Post:
2009-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-16', 'studyFirstSubmitDate': '2009-09-07', 'studyFirstSubmitQcDate': '2009-09-10', 'lastUpdatePostDateStruct': {'date': '2010-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HRV values', 'timeFrame': '5 minutes after drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Levobupivacaine', 'HRV', 'Spinal Anesthesia', 'Responses of ANS to these two drugs'], 'conditions': ['Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare if the effect of levobupivacaine on autonomic nervous system smaller than that of bupivacaine.', 'detailedDescription': 'Obtain the heart rate variability (in means and standard deviation, including the high frequency, low frequency and its ratio) data of before and after spinal anesthesia with ECG (and Heart Rate Variability Analyzer) in 2 groups. Meanwhile, record the blood pressure on each subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indicated for spinal anesthesia\n\nExclusion Criteria:\n\n* Allergic reaction to local anesthetics\n* Coagulopathy\n* Severe spinal deformity\n* Cardiac diseases\n* Metabolic diseases (such as DM, thyroid or adrenal diseases)'}, 'identificationModule': {'nctId': 'NCT00974961', 'acronym': 'HRV', 'briefTitle': 'Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of the Effects of Levobupivacaine and Bupivacaine on Heart Rate Variability in Spinal Anesthesia', 'orgStudyIdInfo': {'id': '200903050M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levobupivacaine', 'description': 'Lumbar puncture with Levobupivacaine for spinal anesthesia', 'interventionNames': ['Drug: bupivacaine, levobupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'Lumbar puncture with Bupivacaine for spinal anesthesia', 'interventionNames': ['Drug: bupivacaine, levobupivacaine']}], 'interventions': [{'name': 'bupivacaine, levobupivacaine', 'type': 'DRUG', 'description': 'intrathecal injection 15\\~20mg(for Levobupivacaine) or 10\\~15mg(for Bupivacaine) once', 'armGroupLabels': ['Bupivacaine', 'Levobupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '640', 'city': 'Yun-Lin County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Yu Chen', 'role': 'CONTACT', 'email': 'hitantc@gmail.com'}], 'facility': 'Department of Anesthesiology, National Taiwan University Hospital, Yun-Lin Branch'}], 'centralContacts': [{'name': 'Shih-Yu Chen, M.D.', 'role': 'CONTACT', 'email': 'hitantc@gmail.com', 'phone': '886-5-5323911', 'phoneExt': '5202'}], 'overallOfficials': [{'name': 'Shih-Yu Chen', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shihyu,Chen / Attending Stuff', 'oldOrganization': 'Attending Stuff of Department of Anesthesiology'}}}}