Effect of Inhalatory Sedation in Subarachnoid Hemorrhage (INSPIRE)

February 5, 2024 updated by: Maurizio Berardino, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Effect of Inhalatory Sedation on Cerebral Perfusion 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Torino, Italy, 10126
        • AOU Città della Salute e della Scienza - Presidio CTO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhalatory group
Patience with severe SAH (WFNS > 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane
Drug: Isoflurane Inhal Soln
Administration of isofluorane in patients with severe SAH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in intracranial pressure during isoflurane delivery
Time Frame: 20 minutes
We evaluate if isofluorane create an increase in ICP trough continuous monitoring.
20 minutes
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
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Maurizio Berardino, MD, AOU Città della Salute e della Scienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0076379

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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