Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
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).

Official Title
-----------------
Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Drug: Isoflurane Inhal Soln


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) ≥ 3. 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. Exclusion Criteria: Documented outcomes of cerebrovascular disease Patients with acute heart failure related to ESA State of pregnancy Patients with CLCR < 30 mL/min

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhalatory group<br>Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane | Drug: Isoflurane Inhal Soln<br>* Administration of isofluorane in patients with severe SAH<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral blood flow recondtion | 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 | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intracranial pressure during isoflurane delivery | We evaluate if isofluorane create an increase in ICP trough continuous monitoring. | 20 minutes | 
| Changes in blood pressure during isoflurane delivery | By its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perfusion, isofluorane, inhalatory, sedation