Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT06352593
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vasospasm', 'timeFrame': '14 days after intervention', 'description': 'Vasospasm is quantified as the percent reduction in arterial diameter between baseline and digital subtraction catheter angiography (DSA). A global assessment of vasospasm will then made and classified as none/mild (0% to 33%), moderate (34% to 66%), or severe (67% to 100%).'}], 'secondaryOutcomes': [{'measure': 'Incidence of morbidity and mortality (M/M)', 'timeFrame': '6 weeks after intervention', 'description': 'Morbidity and mortality (M/M) is defined as at least one of the following: death within 6 weeks of subarachnoid hemorrhage (SAH) from any cause; new cerebral infarct within 6 weeks of subarachnoid hemorrhage(SAH) compared with post-procedure computed tomography (CT) scan; delayed ischemic neurological deficit (DIND) due to vasospasm within 14 days of subarachnoid hemorrhage (SAH); and rescue therapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Infusion', 'Endovascular', 'Aneurysmal Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.', 'detailedDescription': 'Aneurysmal subarachnoid hemorrhage is a sudden, life-threatening emergency caused by bleeding in the subarachnoid space between the brain and skull. Cerebral vasospasm (VSP) is the leading risk factor of neurological deterioration (i.e., delayed cerebral ischemia \\[DCI\\] and cerebral infarction) after aneurysmal subarachnoid hemorrhage (SAH) and a cause of morbidity and mortality.\n\nDexmedetomidine (DEX) is a highly selective α-2 adrenergic receptor agonist. The α -2 receptor agonists have a long track record of use for sedation and analgesia. It has been shown that α -2 agonists are neuroprotective in craniocerebral and subarachnoid injuries. Dexmedetomidine has a significant effect on the central nervous system and decreases the blood flow in the brain and the requirement or needs for cerebral oxygen. It also modifies memory and enhances cognitive ability effects like sedation, analgesic, and anxiolytics. Dexmedetomidine is shown to decrease catecholamine in the brain and improves the perfusion ability in the penumbra. The glutamate level is significantly reduced by Dexmedetomidine (DEX), and so injuries at the cellular level is reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>18 years.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) I-III\n* Unruptured subarachnoid hemorrhage (SAH) confirmed by digital subtraction catheter angiography (DSA) undergoing endovascular intervention with general anesthesia.\n\nExclusion Criteria:\n\n* Subarachnoid hemorrhage (SAH) from a lesion other than a ruptured saccular aneurysm.\n* Intraventricular or intracerebral blood in the absence of localized thick or diffuse Subarachnoid hemorrhage (SAH).\n* No or localized thin subarachnoid hemorrhage (SAH) on computed tomography (CT).\n* Cerebral vasospasm on admission digital subtraction catheter angiography (DSA).\n* Hypotension (systolic blood pressure 90 mm Hg) refractory to fluid therapy.\n* Neurogenic pulmonary edema.\n* Cardiac failure requiring inotropic support.\n* Severe or unstable concomitant condition or disease or chronic condition.\n* Kidney and/or liver disease.\n* Prior cerebral damage on computed tomography (CT) scan such as stroke (\\>2 cm maximum diameter).\n* Pregnancy.\n* Traumatic brain injury.\n* Previously treated cerebral aneurysm.\n* Arterial venous malformation.\n* Pre-existing cerebrovascular disorder that will affect diagnosis and evaluation of Subarachnoid hemorrhage (SAH).\n* Ischemic heart disease or second or third-degree atrioventricular block.\n* Long-term abuse of alcohol, opioids, or sedative-hypnotic drugs.\n* Obesity (body mass index \\[BMI\\] \\>30 kg/m2).'}, 'identificationModule': {'nctId': 'NCT06352593', 'briefTitle': 'Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR557/2/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group D (Dexmedetomidine)', 'description': 'Patients will be administered Dexmedetomidine 0.5 μg/kg for 10 min and then 0.4 μg/kg/h adjusted to 0.2-0.6 μg/kg/h.', 'interventionNames': ['Drug: Intraoperative Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C (placebo group)', 'description': 'Patients will receive normal saline (control group) .', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Intraoperative Dexmedetomidine', 'type': 'DRUG', 'description': 'Patients will be administered DEX 0.5 μg/kg for 10 min and then 0.4 μg/kg/h adjusted to 0.2-0.6 μg/kg/h.', 'armGroupLabels': ['Group D (Dexmedetomidine)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients will receive normal saline.', 'armGroupLabels': ['Group C (placebo group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'ElGharbia', 'country': 'Egypt', 'facility': 'Tanta University Hospitals', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}