Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT07101367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomized Double blinded clinical trial'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control group without any medications Dexmedetomidine group Methylprednisolone group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-31', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induced inflammatory response', 'timeFrame': 'First 24 hours post cardio-pulmonary bypass', 'description': 'Effect of both drugs on attenuating induced inflammatory response'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'First 24 hours post cardio-pulmonary bypass', 'description': 'Assesment of post operative cognitive function and occurnce of post operative delerium using CAM-ICU score'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Systemic Inflammatory Response Syndrome', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'A comparison between precedex versus solumedrol as anti-inflammatory stress response inhibitors in patients undergoing on-pump CABG using different inflammatroy response parameters and the outcome of the drugs on the cognitive and cardiac status post extubation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 21-60 years.\n2. Sex: Both sexes.\n3. American Society of Anaesthesiologists (ASA) Physical Status Class II, and III.\n4. Scheduled for CABG on cardio-pulmonary bypass.\n\nExclusion Criteria:\n\n1. Declining to give a written informed consent.\n2. History of allergy to the medications used in the study.\n3. Psychiatric disorders.\n4. Significant cognitive dysfunction.\n5. American Society of Anesthesiologists (ASA) Physical Status Class IV.\n6. Chronic liver or kidney disease.\n7. Poor systolic function ( Ejection fraction \\< 40% ).\n8. Pregnancy.\n9. Redo CABG.\n\n9.Infection during the week preceding surgery white blood cell count over 11,000 mm3 10.Pre-operative use of antibiotics or corticosteroids.'}, 'identificationModule': {'nctId': 'NCT07101367', 'briefTitle': 'A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG', 'orgStudyIdInfo': {'id': 'FMASU MD219/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU', 'interventionNames': ['Drug: Normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'To be diluted in 10 ml normal saline then given after induction of anesthesia then followed by normal saline infusion till extubation in ICU', 'interventionNames': ['Drug: Methylprednisolone']}], 'interventions': [{'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Control group (placebo)'], 'description': 'After induction of anesthesia give 10 ml of normal saline then followed by infusion of normal saline till extubation of patient in ICU', 'armGroupLabels': ['Control']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex (active comparator)'], 'description': 'After induction of anesthesia give loading dose of precedex 1 mcg/kg diluted in 10 ml normal saline then attach syringe pump of precedex infusion of 0.5mcg/kg/hr till extubation in ICU', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Solumedrol (active comparator)'], 'description': 'After induction of anesthesia give solumedrol of a dose 10mg/kg diluted in 10ml of normal saline followed by a normal saline infusion till the extubation of the patient in the ICU', 'armGroupLabels': ['Methylprednisolone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Assem Abourawash, Masters', 'role': 'CONTACT', 'email': 'assemahmed999@gmail.com', 'phone': '00201064013278'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}