Effect of Inhalatory Sedation in Subarachnoid Hemorrhage
NCT ID: NCT05213832
Last Updated: 2024-02-07
Study Results
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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COMPLETED
PHASE2
11 participants
INTERVENTIONAL
2020-06-26
2022-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
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
Isoflurane Inhal Soln
Administration of isofluorane in patients with severe SAH
Interventions
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Isoflurane Inhal Soln
Administration of isofluorane in patients with severe SAH
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with acute heart failure related to ESA
* State of pregnancy
* Patients with CLCR \< 30 mL/min
18 Years
64 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Maurizio Berardino
Director of Anesthesia and Intensive Care Unit Departement
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
Countries
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Other Identifiers
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0076379
Identifier Type: -
Identifier Source: org_study_id
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