Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-20 @ 9:33 AM
Study NCT ID:
NCT02577432
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2015-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-19', 'studyFirstSubmitDate': '2015-10-10', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.', 'timeFrame': 'intraoperative'}, {'measure': 'incidence of hypotension', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spinal anesthesia'], 'conditions': ['Cesarean Section']}, 'descriptionModule': {'briefSummary': 'Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.\n\nObjectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.\n\nDesign: A randomized, controlled clinical trial.\n\nSetting: Single medical center from 5/2013 to 10/2014.\n\nPatients \\& Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.\n\nPatients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parturient at full term.\n* Must be elective cesarean section.\n* Must be uncomplicated pregnancy\n\nExclusion Criteria:\n\n* Body weight \\<50 kg or \\>90 kg\n* Height ˂150 cm or \\>170 cm.\n* Pre-eclampsia.\n* Any major systemic disease.\n* Contraindication to regional anesthesia.\n* Allergy to used medications.'}, 'identificationModule': {'nctId': 'NCT02577432', 'briefTitle': 'Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Dr. Soliman Fakeeh Hospital'}, 'officialTitle': 'Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension', 'orgStudyIdInfo': {'id': '01/REC/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '(S) separate.', 'description': 'fentanyl and hyperbaric bupivacaine (sequentially)', 'interventionNames': ['Drug: fentanyl', 'Drug: Hyperbaric bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(M) mixed', 'description': 'fentanyl and hyperbaric bupivacaine.(mixed)', 'interventionNames': ['Drug: fentanyl', 'Drug: hyperbaric bupivacaine']}], 'interventions': [{'name': 'fentanyl', 'type': 'DRUG', 'description': 'Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.', 'armGroupLabels': ['(S) separate.']}, {'name': 'fentanyl', 'type': 'DRUG', 'description': 'Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.', 'armGroupLabels': ['(M) mixed']}, {'name': 'Hyperbaric bupivacaine', 'type': 'DRUG', 'description': 'Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.', 'armGroupLabels': ['(S) separate.']}, {'name': 'hyperbaric bupivacaine', 'type': 'DRUG', 'description': 'Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.', 'armGroupLabels': ['(M) mixed']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amr A Keera, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Benha Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Soliman Fakeeh Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Dr. Amr Aly Ismail Keera', 'investigatorAffiliation': 'Dr. Soliman Fakeeh Hospital'}}}}