Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-01 @ 11:07 PM
Study NCT ID:
NCT03834259
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2019-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077708', 'term': 'Sitting Position'}, {'id': 'D016683', 'term': 'Supine Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2019-02-05', 'studyFirstSubmitQcDate': '2019-02-06', 'lastUpdatePostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'systolic arterial hypotension', 'timeFrame': 'every 3 minutes until the delivery and every 5 minutes until the end of surgery', 'description': 'reduction of \\>25% in the basal systolic arterial pressure'}], 'secondaryOutcomes': [{'measure': 'sensory block', 'timeFrame': '10 minutes after spinal block', 'description': 'assesment of the time to reach T12 level with pin prick test'}, {'measure': 'ephedrine requirement time', 'timeFrame': '1 hour after spinal block', 'description': 'the time to first administration of ephedrine as minutes after spinal block'}, {'measure': 'amount of ephedrine', 'timeFrame': '1 hour after spinal block', 'description': 'administrated total ephedrine dosage as mg during surgery'}, {'measure': 'surgeon and patient satisfaction', 'timeFrame': '24 hours after spinal block', 'description': '1= poor, 2=fair, 3= good, 4= very good'}, {'measure': 'motor block', 'timeFrame': '24 hours after spinal block', 'description': 'time to Bromage Score 0 after applying spinal block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal anaesthesia', 'ephedrine'], 'conditions': ['Hypotension', 'Spinal Anaesthesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'the study was designed in caesarean section operations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 - 45 years,\n* ASA physical status\n* I - II,\n* BMI of 25-30\n* who were undergoing elective CS\n\nExclusion Criteria:\n\n* vertebral anomaly,\n* peripheral vascular disease,\n* cardiovascular or psychiatric disorder,\n* severe anemia,\n* coagulopathy\n* infection in the intervention region'}, 'identificationModule': {'nctId': 'NCT03834259', 'briefTitle': 'The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Umraniye Education and Research Hospital'}, 'officialTitle': 'The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption', 'orgStudyIdInfo': {'id': 'GK12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '12.5 mg 0.5% hyperbaric bupivacaine', 'interventionNames': ['Procedure: sitting position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '10 mg 0.5% hyperbaric bupivacaine', 'interventionNames': ['Procedure: supine position']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': '12.5 mg 0.5% hyperbaric bupivacaine', 'interventionNames': ['Procedure: supine position']}], 'interventions': [{'name': 'sitting position', 'type': 'PROCEDURE', 'description': 'keeping the patient in a sitting position after spinal anaesthesia', 'armGroupLabels': ['Group 1']}, {'name': 'supine position', 'type': 'PROCEDURE', 'description': 'keeping the patient in supine position after spinal anaesthesia', 'armGroupLabels': ['Group 2', 'Group 3']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Gulsah Karaoren', 'investigatorAffiliation': 'Umraniye Education and Research Hospital'}}}}