Vasodilatatory effect of inhalatory sedation in patients who suffer from cerebral artery aneurysm rupture

Phase 1

• Conditions: Patients with non traumatic subarachnoid hemorrhage (WFNS = 3 -5); MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-003697-27-IT
• Lead Sponsor: AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Age > 18 years old
Diagnosis of non-traumatic SAH
Neurological and/or systemic presentation that requires support of vital functions and sedation.
ICP monitoring
Patients with vasospasm
Acceptance of informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the aim of the study is to assest the efficacy of inhalatory anestetic as cerebral vasodilatatory in prevention of vasospasm. This complication occurs in 25% of patients affected by subarachnoid hemorrhage.<br>the assessment of perfusion CT allows the ipoperfused area detection, verifing the efficacy of isoflurane's vasodilatatory effect.;Secondary Objective: Evaluate the safety of isoflurane during its vasodilatatory effect on cerebral blood volume and sistemic perfusion.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 20 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in intracranial pressure during isoflurane delivery<br>Changes in blood pressure during isoflurane delivery;Timepoint(s) of evaluation of this end point: 20 minutes