Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 6:29 PM
Study NCT ID:
NCT05091294
Status:
COMPLETED
Last Update Posted:
2022-02-04
First Post:
2021-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Injection Rate of Local Anesthetic in Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-31', 'studyFirstSubmitDate': '2021-10-12', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensory block', 'timeFrame': '2 minutes interval', 'description': 'The time to reach the sufficient sensory block and maximum level of sensory block was significantly shorter in Group S'}, {'measure': 'Hypotension', 'timeFrame': '2 minutes interval', 'description': 'The time to onset of hypotension was significantly shorter in Group F'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, Spinal', 'Anesthesia, Obstetrical']}, 'descriptionModule': {'briefSummary': 'This randomized double-blind study aimed to compare the effects of two different subaracnoid lokal anesthetic injection rate in cesarean section. Totally 67 patients were included. The groups were compared in terms of maximum sensory and motor block level, time to reach T6 level, hemodynamic changes and nausea- vomiting saved.', 'detailedDescription': 'A total of 67 patients 18-40 years undergoing cesarean, who were graded as American Society of Anesthesiologists physical status were randomly allocated into two groups, 120-sn injection time (n=34, Group F), 15-sn injection time (n=33, Group S). When the level of the sensory block achieve the T6 level the surgery was let to begin. The groups were compared in terms of hemodynamic values, use of efedrin, the time to achieve sensory block to the T6 level, maximum sensory block level and motor block level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'All patients are pregnant.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anesthesiologists risk score (ASA) I-II risk status\n* Singleton pregnancy aged\n* Between 18-40 years\n\nExclusion Criteria:\n\n* Pregnant women with contraindications for spinal anesthesia;\n* Placental anomaly;\n* Hypertension\n* Cardiac disease\n* Vascular disease\n* Hepatic disease\n* Renal disease\n* Hemodynamic instability\n* Spinal deformity;\n* Severe mental retardation\n* Weight \\< 50 kg or \\>110 kg; height \\< 140 cm or \\> 180 cm\n* Metabolic and Acid-base balance disorders\n* Emergency patients'}, 'identificationModule': {'nctId': 'NCT05091294', 'briefTitle': 'The Effect of Injection Rate of Local Anesthetic in Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': 'Does the Injection Rate of Local Anesthetic Affect the Onset of Sensory Block and Incidence of Hypotension in Caesarean Section', 'orgStudyIdInfo': {'id': '2020-52'}, 'secondaryIdInfos': [{'id': 'Ahmet Beşir', 'type': 'OTHER', 'domain': 'KaradenizTU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group S:33', 'description': '120-second local anesthesic (% 0,5 Bupivacaine) injection time', 'interventionNames': ['Other: Local anesthetic injection rate in spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group F:34', 'description': '15-second local anesthesic(% 0,5 Bupivacaine) injection time', 'interventionNames': ['Other: Local anesthetic injection rate in spinal anesthesia']}], 'interventions': [{'name': 'Local anesthetic injection rate in spinal anesthesia', 'type': 'OTHER', 'description': 'Administering intrathecal local anesthetics for all patients according to height and weight.', 'armGroupLabels': ['Group F:34', 'Group S:33']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Karadeniz Technical University', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'overallOfficials': [{'name': 'Ersagun tugcugil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KARADENİZ TEKNİK ÜNİVERSİTESİ DEPARTMENT OF ANESTHESİOLOGİA AND REANİMATİON'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof.', 'investigatorFullName': 'Ersagun Tugcugil', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}