Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Placebo
- Conditions
- Dexmedetomidine
- Sponsor
- Tanta University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Incidence of vasospasm
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.
Detailed Description
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.
Investigators
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Aged \>18 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) I-III
- •Unruptured subarachnoid hemorrhage (SAH) confirmed by digital subtraction catheter angiography (DSA) undergoing endovascular intervention with general anesthesia.
Exclusion Criteria
- •Subarachnoid hemorrhage (SAH) from a lesion other than a ruptured saccular aneurysm.
- •Intraventricular or intracerebral blood in the absence of localized thick or diffuse Subarachnoid hemorrhage (SAH).
- •No or localized thin subarachnoid hemorrhage (SAH) on computed tomography (CT).
- •Cerebral vasospasm on admission digital subtraction catheter angiography (DSA).
- •Hypotension (systolic blood pressure 90 mm Hg) refractory to fluid therapy.
- •Neurogenic pulmonary edema.
- •Cardiac failure requiring inotropic support.
- •Severe or unstable concomitant condition or disease or chronic condition.
- •Kidney and/or liver disease.
- •Prior cerebral damage on computed tomography (CT) scan such as stroke (\>2 cm maximum diameter).
Arms & Interventions
Group C (placebo group)
Patients will receive normal saline (control group) .
Intervention: Placebo
Group D (Dexmedetomidine)
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.
Intervention: Intraoperative Dexmedetomidine
Outcomes
Primary Outcomes
Incidence of vasospasm
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%).
Secondary Outcomes
- Incidence of morbidity and mortality (M/M)(6 weeks after intervention)