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

Effect of inhalatory sedation on cerebral perfusion in subarchnoid hemorrhage - INSPIRE- INalatory Sedation and cerebral Perfusion In subaRachnoid hEmorrage

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003697-27-IT

Enrollment

Registered

2021-05-20

Start date

2020-05-04

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non traumatic subarachnoid hemorrhage (WFNS = 3 -5) MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: AERRANE - 100 ML LIQUIDO PER INALAZIONEFLACONE 100 ML Product Name: AERRANE Product Code: [29033014] Pharmaceutical Form: Pressurised inhalation, solution CAS Number: 26675-46-7 Current S

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

Measure	Time frame
Secondary end point(s): Changes in intracranial pressure during isoflurane delivery Changes in blood pressure during isoflurane delivery;Timepoint(s) of evaluation of this end point: 20 minutes	—

Countries

Italy

Contacts

Public ContactDIPARTIMENTO DI ANESTESIA, RIANIMAZ

AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - PRESIDIO CTO

mberardino@cittadellasalute.to.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026