Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 11:53 PM
Study NCT ID:
NCT03024957
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2017-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the base line in cellular immunity', 'timeFrame': 'Baseline , immediate postoperative, 4 hours postoperative and 24 hours postoperative', 'description': 'CD3, CD4, CD4/CD8, CD16, CD56'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Cytokines', 'timeFrame': 'Baseline, immediate postoperative, 4 hours postoperative and 24 hours postoperative', 'description': 'interleukin-1B, interleukin-6, interleukin-10 and tumor necrosis factor'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['morphine', 'dexmedetomidine', 'immune system'], 'conditions': ['Immune System Suppression']}, 'descriptionModule': {'briefSummary': 'this work aims to investigate the effect of intrathecal administration of Morphine, Dexmedetomidine or both in combination on cellular immunity and cytokine production in patients undergoing major abdominal cancer surgeries.', 'detailedDescription': 'Intrathecal (IT) adjuvants prolong the duration of spinal anesthesia and postoperative analgesia thereby reducing the requirement of postoperative supplemental analgesics. The incorporation of adjuvants also lowers the overall dose of local anesthetic and hence associated side effects. Morphine has been used widely to alleviate various types of pain and to supplement general anesthesia. On the other hand, morphine has been reported to possess some immunosuppressive effects. Postoperative immunity is also important in conjunction with defence against malignant tumour. Dexmedetomidine is a highly selective α2 agonist with analgesia, sedation, anxiolysis, and sympatholysis as its useful pharmacological actions. The extended analgesic efficacy of IT dexmedetomidine (ITD) in the postoperative period has been shown in a few clinical studies. In addition, current insights have identified that dexmedetomidine has a capacity in inhibiting the overproduction of a variety of inflammatory molecules including TNF-α, IL-1β, and IL-6 in several acute inflammatory animal models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II patients scheduled for major abdominal cancer surgeries\n\nExclusion Criteria:\n\n* patients with known allergy to the study drugs,\n* significant cardiac, respiratory, renal or hepatic disease,\n* drug or alcohol abuse,\n* psychiatric illness that would interfere with perception and assessment of pain.'}, 'identificationModule': {'nctId': 'NCT03024957', 'briefTitle': 'Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Intrathecal Morphine, Dexmedetomidine or Both in Combination to Bupivacaine on Immunity in Patients Undergoing Major Abdominal Cancer Surgeries', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine group', 'description': 'patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine in 1 mL volume intrathecally.', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine group', 'description': 'patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 0.5 mg morphine sulphate in 1 mL volume intrathecally.', 'interventionNames': ['Drug: Morphine Sulfate', 'Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine + morphine group', 'description': 'patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 mL volume and 5 μg of dexmedetomidine plus 0.5 mg of morphine sulphate in 1 mL volume intrathecally.', 'interventionNames': ['Drug: Morphine Sulfate', 'Drug: Dexmedetomidine', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Morphine Sulfate', 'type': 'DRUG', 'description': 'Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate .', 'armGroupLabels': ['Dexmedetomidine + morphine group', 'Morphine group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.', 'armGroupLabels': ['Dexmedetomidine + morphine group', 'Dexmedetomidine group']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.', 'armGroupLabels': ['Dexmedetomidine + morphine group', 'Dexmedetomidine group', 'Morphine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171516', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia, ICU and pain managment', 'investigatorFullName': 'Shereen Mamdouh', 'investigatorAffiliation': 'Assiut University'}}}}