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
- Contact Person Email
- juanalvarezcienfuegos@gmail.com
- 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.