Clinical trial • Phase III • Other|Cardiology

Sevoflurane for Acute ischemic stroke

Phase III trial of Sevoflurane for Acute ischemic stroke.

Overview

Trial Therapeutic Area
Other|Cardiology
Trial Disease
Acute ischemic stroke
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-01-2026
First CTIS Authorization Date
07-04-2026

Trial design

Randomised, propofol fresenius 20 mg/ml emulsión inyectable y para perfusión efg (propofol), iv injection/infusion; dosing information provided: up to 12 mg/kg/h (dose unit mg/kg/h).-controlled Phase III trial across 7 sites in Spain.

Randomised
Yes
Comparator
Propofol Fresenius 20 mg/ml emulsión inyectable y para perfusión EFG (propofol), IV injection/infusion; dosing information provided: up to 12 mg/kg/h (dose unit mg/kg/h).
Target Sample Size
330
Trial Duration For Participant
90

Eligibility

Recruits 330 No vulnerable populations selected. Consent must be provided by the patient or by the family member/legal representative (ability to provide informed consent is an inclusion criterion). Deferred consent procedures are referenced in the trial documents (deferred consent ICF available)..

Vulnerable Population
No vulnerable populations selected. Consent must be provided by the patient or by the family member/legal representative (ability to provide informed consent is an inclusion criterion). Deferred consent procedures are referenced in the trial documents (deferred consent ICF available).

Inclusion criteria

  • {"criterion_text":"- Age >18 years\n- Acute ischemic stroke within 24 hours from the last time seen well (LTSW), undergoing emergency endovascular treatment (EVT), with or without prior thrombolysis.\n- Intracranial occlusion in the anterior circulation, including occlusions in segments M1 and M2 of the middle cerebral artery and/or the terminal portion of the internal carotid artery (TICA). Tandem lesions affecting extracranial segments of the internal carotid artery will also be included.\n- Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline computed tomography (CT).\n- Pre-stroke modified Rankin Scale (mRS) score of 0–3.\n- Indication for general anesthesia at the start of the procedure (<30 minutes from femoral puncture) due to one of the following reasons: • Confusion or lack of patient cooperation. • Technical difficulties, such as complex arterial access, vascular tortuosity, need for extra- or intracranial stent placement, distal/medium vessel occlusions, among others. • Treating team's preference.\n- Ability of the patient or the family member/legal representative to provide informed consent."}

Exclusion criteria

  • {"criterion_text":"- Presence of hemorrhagic lesions on baseline CT.\n- Occlusions in the anterior cerebral artery (ACA).\n- Occlusions in the posterior circulation, including vertebral, basilar, or posterior cerebral arteries (PCA).\n- Hemodynamic instability.\n- Acute respiratory failure requiring orotracheal intubation\n- Decision to perform general anesthesia due to complications during the endovascular treatment.\n- Known hypersensitivity to propofol, sevoflurane, or any of their excipients.\n- Personal or family history of malignant hyperthermia, or suspected susceptibility to malignant hyperthermia (contraindication to halogenated anesthetics such as sevoflurane).\n- History of a previous severe adverse reaction to halogenated anesthetics, including hepatotoxicity associated with their use."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary outcome of the study will be the final infarct volume (FIV), assessed by Fluid-Attenuated Inversion Recovery (FLAIR) sequence on magnetic resonance imaging (MRI) follow-up at 72 hours post-treatment ± 24 hours.","definition_or_measurement_approach":"Final infarct volume (FIV) assessed by FLAIR MRI at 72 hours post-treatment ±24 hours."}

Recruitment

Planned Sample Size
330
Recruitment Window Months
48
Consent Approach
Consent to be provided by the patient or by a family member/legal representative. Deferred consent procedure is available (documented: L1_SIS and ICF_Deferred consent_FP). No age-specific documents or languages are specified in the available metadata.

Geography

Total Number Of Sites
7
Total Number Of Participants
330

Spain

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
07-04-2026
Processing Time Days
8
Number Of Sites
7
Number Of Participants
330

Sites

Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurology
Contact Person Name
Enrique Jesús Palacio Portilla
Contact Person Email
enjepalacio@hotmail.com
Site Name
University Hospital Son Espases
Department Name
Neurology
Contact Person Name
Raquel Delgado Mederos
Contact Person Email
raquel.delgado@ssib.es
Site Name
Hospital Del Mar
Department Name
Neurology
Contact Person Name
Ana Rodríguez Campello
Contact Person Email
92269@hospitaldelmar.cat
Site Name
Hospital Universitario Donostia
Department Name
Neurology
Contact Person Name
Patricia de la Riva Juez
Contact Person Email
patricia.delariva@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Pol Camps Renom
Contact Person Email
PCamps@santpau.cat
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Neurology
Contact Person Name
Juan Álvarez-Cienfuegos Rodríguez
Site Name
Hospital Universitario Miguel Servet
Department Name
Neurology
Contact Person Name
Herbert Daniel Tejada Meza
Contact Person Email
htmeza@gmail.com

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Sevoflurano Baxter 100% líquido para inhalación del vapor EFG
Active Substance
Sevoflurane
Modality
Small molecule
Routes Of Administration
INHALATION
Route
INHALATION
Authorisation Status
Marketing authorisation present: 72200 (ES)
Maximum Dose
3 % (V/V)
Investigational Product Name
Propofol Fresenius 20 mg/ml emulsión inyectable y para perfusión EFG
Active Substance
Propofol
Modality
Small molecule
Routes Of Administration
IV INJECTION, IV INFUSION
Route
IV INJECTION/IV INFUSION
Authorisation Status
Marketing authorisation present: 64.033 (ES)
Frequency
Continuous infusion (mg/kg/h)
Maximum Dose
12 mg/kg/h

Related trials

Other published trials that may interest you.