Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-31 @ 2:26 PM
Study NCT ID:
NCT06315634
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Dexmedetomidine vs Midazolame
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-02-09', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of sensory block', 'timeFrame': '12 hours', 'description': 'Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation'}], 'secondaryOutcomes': [{'measure': 'Incidence of vomiting occurrence', 'timeFrame': '12 hours', 'description': 'The patient will be reported in case of vomiting occurrence'}, {'measure': 'Sedation', 'timeFrame': '12 hours', 'description': "Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain"}, {'measure': 'Change in mean arterial blood pressure', 'timeFrame': '12 hours', 'description': 'Non invasive blood pressure measurement'}, {'measure': 'Duration of motor block', 'timeFrame': '12 hours', 'description': 'Ability of patient to regain full motor power'}, {'measure': 'Change in heart rate', 'timeFrame': '12 hours', 'description': 'Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries', 'detailedDescription': 'Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing lower limb orthopedic cancer surgery.\n* ASA I, II, III.\n* Age 20 to 70 year\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Age less than 20 and older than 70.\n* ASA IV, V.\n* patients' refusal.\n* patients with coagulopathy.\n* patients with severe valvular stenosis\n* patients with infection at site of injection"}, 'identificationModule': {'nctId': 'NCT06315634', 'briefTitle': 'Intrathecal Dexmedetomidine vs Midazolame', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries', 'orgStudyIdInfo': {'id': 'AP210330102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Heavy Bupivacaine plus normal saline', 'description': '2.5 ml of 0.5% hyperbaric Bupivacaine plus 0.5 ml 0.9 % saline', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'EXPERIMENTAL', 'label': 'Heavy Bupivacaine plus dexmedetomidine', 'description': '2.5 ml of 0.5% hyperbaric Bupivacaine plus 5 micrograms dexmedetomidine in 0.5 ml 0.9 % saline', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Bupivacain']}, {'type': 'EXPERIMENTAL', 'label': 'Heavy Bupivacaine plus midazolam', 'description': '2.5 ml of 0.5% hyperbaric Bupivacaine plus 2 milligrams midazolam in 0.5 ml 0.9 % saline', 'interventionNames': ['Drug: Midazolam', 'Drug: Bupivacain']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Spinal dexmedetomidine'], 'description': '5 micrograms intrathecal dexmedetomidine', 'armGroupLabels': ['Heavy Bupivacaine plus dexmedetomidine']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['Spinal midazolam'], 'description': '2 milligrams intrathecal midazolam', 'armGroupLabels': ['Heavy Bupivacaine plus midazolam']}, {'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['Spinal bupivacaine'], 'description': '12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine', 'armGroupLabels': ['Heavy Bupivacaine plus dexmedetomidine', 'Heavy Bupivacaine plus midazolam', 'Heavy Bupivacaine plus normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National cancer institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Elwasef, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NCI Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Mohammed Said Nasef Zedan', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}