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Effect of Inhalatory Sedation in Subarachnoid Hemorrhage (INSPIRE)

A

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status and phase

Completed
Phase 2

Conditions

Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage

Treatments

Drug: Isoflurane Inhal Soln

Study type

Interventional

Funder types

Other

Identifiers

NCT05213832
0076379

Details and patient eligibility

About

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).

Enrollment

11 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Maurizio Berardino, MD

Data sourced from clinicaltrials.gov

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