Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:07 AM
Study NCT ID:
NCT07064720
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008353', 'term': 'Mannitol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2025-07-06', 'studyFirstSubmitQcDate': '2025-07-06', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'optic nerve sheath diameter', 'timeFrame': '90 minutes'}], 'secondaryOutcomes': [{'measure': 'Postoperative neurologic complications', 'timeFrame': '24 HOURS'}, {'measure': 'Postoperative cardiac complications', 'timeFrame': '24 hours'}, {'measure': 'Duration of hospital stay', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'mannitol'], 'conditions': ['Dexmedetomidine']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. In addition, dexmedetomidine-induced stimulation of the postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA I-II Patients scheduled for elective robot-assisted laparoscopic prostatectomy\n\nExclusion Criteria:\n\n* • ASA physical status \\> II\n\n * Cardiac patients\n * Cerebrovascular disease\n * Glaucoma\n * Hepatic failure\n * Renal failure\n * History of anaphylactic reaction to dexmedetomidine or mannitol\n * Hemodynamic instability\n * Cannot measure ONSD for example due to ophthalmological problems.\n * Any cause of preoperative increase in ICP for example intracranial space occupying lesions.'}, 'identificationModule': {'nctId': 'NCT07064720', 'briefTitle': 'Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure', 'orgStudyIdInfo': {'id': 'MS-50-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (D)', 'description': 'Dexmedetomidine with Mannitol', 'interventionNames': ['Drug: Dexmedetomidine with Mannitol']}, {'type': 'EXPERIMENTAL', 'label': 'Group (M)', 'description': 'Mannitol only', 'interventionNames': ['Drug: Mannitol (20%)']}], 'interventions': [{'name': 'Dexmedetomidine with Mannitol', 'type': 'DRUG', 'description': 'receive 1 mcg/kg of dexmedetomidine added to 0.4 mcg/kg of mannitol', 'armGroupLabels': ['Group (D)']}, {'name': 'Mannitol (20%)', 'type': 'DRUG', 'description': 'receive 0.5 g/kg of mannitol', 'armGroupLabels': ['Group (M)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amr Wahdan', 'role': 'CONTACT', 'email': 'amrwahdan@kasraliny.edu.eg', 'phone': '01001422499'}, {'name': 'Heba Ismail', 'role': 'CONTACT', 'phone': '01220807670'}, {'name': 'Samar Hassan Koshek', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'facility of medicine Cairo university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr Samir Wahdan', 'role': 'CONTACT', 'email': 'amrwahdan@kasraliny.edu.eg', 'phone': '+201001422499'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}