Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 5:53 AM
Study NCT ID:
NCT06748794
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for C-section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002900', 'term': 'Chromosomes, Human, 1-3'}], 'ancestors': [{'id': 'D002877', 'term': 'Chromosomes, Human'}, {'id': 'D033481', 'term': 'Chromosomes, Mammalian'}, {'id': 'D002875', 'term': 'Chromosomes'}, {'id': 'D040342', 'term': 'Genetic Structures'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-19', 'studyFirstSubmitQcDate': '2024-12-19', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': '12 Months', 'description': 'Time from intrathecal drug administration to the first request for additional analgesia by the patient.'}, {'measure': 'Quality of sensory and motor block', 'timeFrame': '12 Months', 'description': 'Onset, level, and duration of sensory block, Onset and duration of motor block, Maximum sensory block level achieved.'}, {'measure': 'Hemodynamic stability', 'timeFrame': '12 months', 'description': 'Incidence and severity of hypotension, bradycardia, or other hemodynamic changes during the perioperative period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of intrathecal midazolam (1 mg) combined with hyperbaric bupivacaine 0.5% (15 mg) for spinal anesthesia in cesarean section patients.', 'detailedDescription': 'The addition of midazolam, a benzodiazepine with analgesic and anxiolytic properties to bupivacaine is hypothesized to enhance the quality of anesthesia and postoperative pain relief without significant side effects. A comparative analysis was conducted to assess sensory and motor block characteristics, postoperative analgesia duration, maternal hemodynamic stability, and neonatal outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'to check the Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for Caesarean Section', 'genderDescription': 'Caesarean Section', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients presented for elective cesarean section.\n* All ASA I \\& II patients .\n* Age between 18 to 35 years.\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia.\n* Patient not willing or previous bad experience with it.\n* All ASA III \\& IV class was excluded from the study.\n* Patients with documented bleeding disorders i.e. low platelet count, deranged PT/APTT/INR, DIC etc.\n* Hypertensive patients\n* Patients with Diabetes mellitus.\n* Obese patients BMI \\>30.\n* PIH (pre- eclampsia and eclapmsia)"'}, 'identificationModule': {'nctId': 'NCT06748794', 'briefTitle': 'Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for C-section', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Effects of Intrathecal Midazolam (1mg) With Hyperbaric Bupivacaine 0.5% (15mg) for Spinal Anesthesia for Caesarean Section', 'orgStudyIdInfo': {'id': 'MSAHS/Batch-Spring23/049'}}, 'armsInterventionsModule': {'interventions': [{'name': 'group 1', 'type': 'DIAGNOSTIC_TEST', 'description': 'A comparative analysis was conducted to assess sensory and motor block characteristics, postoperative analgesia duration, maternal hemodynamic stability, and neonatal outcomes. Results demonstrated that intrathecal midazolam significantly prolonged postoperative analgesia and reduced analgesic requirements while maintaining hemodynamic stability and maternal-neonatal safety. This combination provides a potential enhancement to spinal anesthesia techniques, improving maternal comfort and overall perioperative outcomes in obstetric patients.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nowshera', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Nowshera', 'geoPoint': {'lat': 34.01583, 'lon': 71.98123}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}