Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

NCT05213832 | Completed Phase 2 DMC

• 1 other identifier: 0076379
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage

Keywords

perfusion; isofluorane; inhalatory; sedation

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow recondtion

  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 Outcomes (2)

• Changes in intracranial pressure during isoflurane delivery

  20 minutes

• Changes in blood pressure during isoflurane delivery

  20 minutes

Study Arms (1)

Inhalatory group

EXPERIMENTAL

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

Interventions

Isoflurane Inhal Soln DRUG

Administration of isofluorane in patients with severe SAH

Inhalatory group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Documented outcomes of cerebrovascular disease
• Patients with acute heart failure related to ESA
• State of pregnancy
• Patients with CLCR \< 30 mL/min

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

AOU Città della Salute e della Scienza - Presidio CTO

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Maurizio Berardino, MD

  AOU Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesia and Intensive Care Unit Departement

Study Record Dates

• First Submitted: January 16, 2022
• First Posted: January 28, 2022
• Study Start: June 26, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (1)