Role of Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of vasospasm
研究概览
简要总结
The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
- •Pregnancy.
- •Traumatic brain injury.
- •Previously treated cerebral aneurysm.
- •Arterial venous malformation.
- •Pre-existing cerebrovascular disorder that will affect diagnosis and evaluation of Subarachnoid hemorrhage (SAH).
- •Ischemic heart disease or second or third-degree atrioventricular block.
- •Long-term abuse of alcohol, opioids, or sedative-hypnotic drugs.
- •Obesity (body mass index [BMI] >30 kg/m2).
研究组 & 干预措施
Group C (placebo group)
Patients will receive normal saline (control group) .
干预措施: Placebo (Other)
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.
干预措施: Intraoperative Dexmedetomidine (Drug)
结局指标
主要结局
Incidence of vasospasm
时间窗: 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%).
次要结局
- Incidence of morbidity and mortality (M/M)(6 weeks after intervention)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University