Skip to main content
OpenTrials
Completed

NCT Number: NCT05213832

Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AOU Città della Salute e della Scienza - Presidio CTO

Torino, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoflurane Inhal Soln

Drug

Administration of isofluorane in patients with severe SAH

Primary outcomes

  1. Cerebral blood flow recondtion

    Time frame: 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 outcomes

  1. Changes in intracranial pressure during isoflurane delivery

    Time frame: 20 minutes

    We evaluate if isofluorane create an increase in ICP trough continuous monitoring.

  2. Changes in blood pressure during isoflurane delivery

    Time frame: 20 minutes

    By its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage

Acronym: INSPIRE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.