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Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05213832
Acronym
INSPIRE
Enrollment
11
Registered
2022-01-28
Start date
2020-06-26
Completion date
2022-12-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage, Subarachnoid Hemorrhage

Keywords

perfusion, isofluorane, inhalatory, sedation

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).

Interventions

DRUGIsoflurane Inhal Soln

Administration of isofluorane in patients with severe SAH

Sponsors

A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral blood flow recondtion20 minutesThe 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

MeasureTime frameDescription
Changes in intracranial pressure during isoflurane delivery20 minutesWe evaluate if isofluorane create an increase in ICP trough continuous monitoring.
Changes in blood pressure during isoflurane delivery20 minutesBy its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026