Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-01-01 @ 3:13 PM
Study NCT ID:
NCT04718259
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2021-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': '90 days', 'description': 'Efficacy of PO analgesia will be determined, by an assistant who will be blinded about the using the observational pain-discomfort scale (OPS), which assesses behavioral parameters that can be evaluated objectively.'}, {'measure': 'Duration of analgesia', 'timeFrame': '90 days', 'description': 'defined as the time elapsed since end of the surgical procedure till OPS reaches \\>11'}, {'measure': 'Post operative resolution of motor block', 'timeFrame': '90 days', 'description': 'will be assessed using Bromage score till complete recovery.'}, {'measure': 'The level of Post operative sedation', 'timeFrame': '90 days', 'description': 'will be assessed at 30 \\& 120 minutes after admission to the recovery room using the modified WilsonSedation Score (WSS)'}, {'measure': 'PO hospital stay', 'timeFrame': '90 days', 'description': 'Duration of PO hospital stay'}], 'secondaryOutcomes': [{'measure': 'The rate of procedural success', 'timeFrame': '90 days', 'description': 'Defined as peak sensory level at least T10, Bromage score at 3 at 10-min after spina block and no response to surgical stimuli once surgery will be allowed to start.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia', 'Children, Only', 'Bupivacaine', 'Midazolam']}, 'descriptionModule': {'briefSummary': 'The study will be carried on children undergoing lower abdominal surgeries. Patients will be randomly categorized into two study groups. Group A will include patients who will receive bupivacaine intrathecal injection without adjuvant. Group B will include patients who will receive bupivacaine and preservative-free midazolam.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children aged 3-12 years, assigned for lower abdominal and pelvic surgeries and will be ASA grade I after obtaining written fully informed parental consent.\n\nExclusion Criteria:\n\n* Patients with congenital anomalies especially of the spine, infections in the skin of the back, had coagulopathy, or allergy to the study drugs and those whose parents refused to give the consent .'}, 'identificationModule': {'nctId': 'NCT04718259', 'briefTitle': 'The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Evaluation of the Intraoperative and PO Analgesic Outcome of Using Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.', 'orgStudyIdInfo': {'id': 'Intrathecal midazolam'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Will include patients who will receive bupivacaine intrathecal injection without adjuvant.', 'interventionNames': ['Drug: intrathecal bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Will include patients who will receive bupivacaine and midazolam.', 'interventionNames': ['Drug: intrathecal bupivacaine', 'Drug: midazolam']}], 'interventions': [{'name': 'intrathecal bupivacaine', 'type': 'DRUG', 'otherNames': ['intrathecal bupivacaine and midazolam'], 'description': 'The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'midazolam', 'type': 'DRUG', 'description': 'midazolam', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00966', 'city': 'Jizan', 'country': 'Saudi Arabia', 'facility': 'Alemeis hospital ksa', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After analyzing the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant anesthesia', 'investigatorFullName': 'MOHAMMED FAWZI ALI ABOSAMAK', 'investigatorAffiliation': 'Tanta University'}}}}