Acute Ischemic Stroke, Large Vessel Occlusion
Conditions
Brief summary
Acute ischemic stroke occurs when a blood clot blocks blood flow to part of the brain. Patients with this condition may require endovascular therapy, a procedure used to remove the clot and restore blood flow. General anesthesia is sometimes needed during this procedure. The SAVE trial compares two medicines used for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy: sevoflurane and propofol. The aim of the study is to determine whether the choice of anesthetic medicine affects the final volume of brain tissue damaged by the stroke. Participants will be randomly assigned to receive either sevoflurane or propofol during general anesthesia. The final volume of the brain infarction will be assessed using magnetic resonance imaging (MRI) approximately 72 hours after treatment. Participants will also be followed for up to 90 days to assess their clinical outcomes. The study plans to include 314 participants across seven hospitals in Spain. The results may help improve understanding of how the choice of anesthetic medicine affects outcomes in patients with acute ischemic stroke treated with endovascular therapy.
Interventions
DRUGSevoflurane
Sevoflurane administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol.
DRUGpropofol (drug)
Propofol administered for general anesthesia in patients with acute ischemic stroke undergoing endovascular therapy, according to the study protocol.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years. * Acute ischemic stroke within 24 hours from last time seen well, requiring emergency endovascular treatment, with or without prior thrombolysis. * Intracranial anterior circulation occlusion, including occlusions of the M1 or M2 segments of the middle cerebral artery and/or the terminal internal carotid artery (TICA). Tandem lesions involving extracranial segments of the internal carotid artery are also eligible. * Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline computed tomography (CT). * Pre-stroke modified Rankin Scale (mRS) score of 0-3. * Indication for general anesthesia at the start of the procedure (within 30 minutes from femoral puncture) due to patient confusion or lack of cooperation, technical difficulties, or the treating team's preference. * Ability to provide informed consent by the patient or by a family member/legal representative.
Exclusion criteria
* Hemorrhagic lesions on baseline CT. * Anterior cerebral artery (ACA) occlusion. * Posterior circulation occlusion, including vertebral, basilar, or posterior cerebral arteries (PCA). * Hemodynamic instability. * Acute respiratory failure requiring orotracheal intubation. * General anesthesia required because of complications during endovascular treatment. * Known hypersensitivity to propofol, sevoflurane, or any of their excipients. * Personal or family history of malignant hyperthermia, or suspected susceptibility to malignant hyperthermia. * History of a previous serious adverse reaction to halogenated anesthetics, including hepatotoxicity associated with their use.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final infarct volume on follow-up brain MRI | 72 hours (±24 hours) after endovascular treatment | Final infarct volume (FIV) will be assessed using the Fluid-Attenuated Inversion Recovery (FLAIR) sequence on follow-up brain magnetic resonance imaging (MRI). Infarcted tissue will be identified and segmented, and the total infarct volume will be quantified in milliliters (mL). Images will be analyzed centrally by trained evaluators blinded to clinical outcomes. |
Countries
Spain
Contacts
CONTACTPol Camps-Renom
Outcome results
None listed