Tanta University Hospitals
Tanta, ElGharbia, 31527, Egypt
NCT Number: NCT06352593
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Tanta, ElGharbia, 31527, Egypt
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.
Dexmedetomidine (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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will receive normal saline.
Time frame: 14 days after intervention
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%).
Time frame: 6 weeks after intervention
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.
Tanta University
Other
Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
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