Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Cerebral blood flow recondtion
研究概览
简要总结
The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.
It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.
Perfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Diagnosis of non-traumatic SAH
- •Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥
- •Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.
- •Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.
- •Acceptance of informed consent.
排除标准
- •Documented outcomes of cerebrovascular disease
- •Patients with acute heart failure related to ESA
- •State of pregnancy
- •Patients with CLCR < 30 mL/min
研究组 & 干预措施
Inhalatory group
Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane
干预措施: Isoflurane Inhal Soln (Drug)
结局指标
主要结局
Cerebral blood flow recondtion
时间窗: 20 minutes
The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan
次要结局
- Changes in blood pressure during isoflurane delivery(20 minutes)
- Changes in intracranial pressure during isoflurane delivery(20 minutes)
研究者
Maurizio Berardino
Director of Anesthesia and Intensive Care Unit Departement
A.O.U. Città della Salute e della Scienza