Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

NCT ID: NCT05213832

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-26

Study Completion Date

2022-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Inhalatory group

Patience with severe SAH (WFNS \> 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane

Group Type EXPERIMENTAL

Isoflurane Inhal Soln

Intervention Type DRUG

Administration of isofluorane in patients with severe SAH

Interventions

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Isoflurane Inhal Soln

Administration of isofluorane in patients with severe SAH

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Berardino

Director of Anesthesia and Intensive Care Unit Departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maurizio Berardino, MD

Role: PRINCIPAL_INVESTIGATOR

AOU Città della Salute e della Scienza

Locations

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AOU Città della Salute e della Scienza - Presidio CTO

Torino, , Italy

Site Status

Countries

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Italy

Other Identifiers

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0076379

Identifier Type: -

Identifier Source: org_study_id

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