Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

Phase 2

Completed

• Conditions: Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage
• Interventions: Drug: Isoflurane Inhal Soln

• Registration Number: NCT05213832
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-26
• Study First Submitted: 2022-01-16
• Study First Submitted QC: 2022-01-16
• Study First Posted: 2022-01-28
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inhalatory group	Isoflurane Inhal Soln	Patience with severe SAH (WFNS \> 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow recondtion	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza - Presidio CTO; 🇮🇹 Torino, Italy