Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— INSPIRE  

Official title:

Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05213832
• Other study ID #: 0076379
• Status: Completed
• Phase: Phase 2
• Start date: June 26, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Isoflurane Inhal Soln
Administration of isofluorane in patients with severe SAH

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza - Presidio CTO	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in intracranial pressure during isoflurane delivery	We evaluate if isofluorane create an increase in ICP trough continuous monitoring.	20 minutes
Secondary	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