Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02563795
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2015-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Spinal Anesthesia in Cesarean Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2015-09-18', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score < 6 with only spinal anesthesia', 'timeFrame': 'Approximately 30 min, during surgery', 'description': 'Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants'}], 'secondaryOutcomes': [{'measure': 'Maternal hypotension', 'timeFrame': 'Approximately 30 min, during surgery', 'description': 'Avoiding maternal hypotension'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spinal anesthesia', 'Cesarean', 'Maternal hypotension'], 'conditions': ['Maternal Hypotension', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cesarean section under spinal anesthesia in obstetric clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant patients\n\nExclusion Criteria:\n\n* Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.'}, 'identificationModule': {'nctId': 'NCT02563795', 'briefTitle': 'Low Dose Spinal Anesthesia in Cesarean Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Does the Reduction of Local Anesthetic Dose Provide Surgical Anesthesia While Avoiding Maternal Hypotension in Obese Pregnant for C/S by Single Shot Spinal Anesthesia?', 'orgStudyIdInfo': {'id': 'ANK-42479'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'Pregnant with BMI\\<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}, {'label': 'Group II', 'description': 'Pregnant with BMI\\<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl', 'interventionNames': ['Drug: Fentanyl']}, {'label': 'Group III', 'description': 'Pregnant with BMI\\>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}, {'label': 'Group IV', 'description': 'Pregnant with BMI\\>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Fentanyl'], 'description': 'To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants', 'armGroupLabels': ['Group I', 'Group III']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Bupivacaine'], 'description': 'To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants', 'armGroupLabels': ['Group II', 'Group IV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06550', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Cigdem Yildirim Guclu', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'CIGDEM YILDIRIM GUCLU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'CIGDEM YILDIRIM GUCLU', 'investigatorAffiliation': 'Ankara University'}}}}