Comparison of Sevoflurane versus Propofol for Anesthetic Maintenance in Patients with Acute Ischemic Stroke Undergoing Mechanical Thrombectomy

The primary objective is to compare the final volume of cerebral infarction at 72 hours via magnetic resonance imaging in patients with acute ischemic stroke undergoing mechanical thrombectomy under general anesthesia, specifically evaluating the maintenance of anesthesia using either sevoflurane or propofol. 5

Secondary objectives include:

• Comparison of final infarct volume via computed tomography at 24 hours as assessed by a blinded Core Lab.
• Assessment of safety variables, including mortality, bronchial aspiration, cardiac conduction block, seizures, and the incidence and severity of procedure-related complications.
• Evaluation of procedural metrics, such as the duration from femoral puncture to the final imaging series.
• Determination of the probability of a good functional outcome at 3 months post-procedure, defined by the modified Rankin scale score of 0–2.

The sponsor did not provide information regarding the total number of participants. The study population consists of both male and female patients diagnosed with acute ischemic stroke. Eligible participants must be adults with an onset of symptoms within 24 hours of the last time seen well. Inclusion criteria require intracranial occlusion in the anterior circulation, such as the middle cerebral artery or terminal internal carotid artery, and an Alberta Stroke Program Early CT Score of 6 or greater. Patients must have a pre-stroke modified Rankin Scale score between 0 and 3. The population includes individuals requiring mechanical thrombectomy under general anesthesia due to technical complexities, patient non-cooperation, or clinician preference. Cerebral infarction volume is assessed via magnetic resonance imaging at 72 hours following the intervention.

This Phase III clinical trial utilizes a design to compare the efficacy of sevoflurane and propofol for anesthetic maintenance in patients diagnosed with acute ischemic stroke undergoing endovascular treatment. Participants are randomly assigned to receive either inhalation vapour or intravenous infusion. The primary objective is to evaluate the final infarct volume, which is assessed via magnetic resonance imaging using the FLAIR sequence at 72 hours post-treatment, within a window of ± 24 hours. The study includes a screening process to identify eligible patients based on specific criteria, such as age, intracranial occlusion location, and ASPECTS score. The study duration for recruitment is estimated to occur between March 2026 and March 2030.

The experimental medication is sevoflurane, administered as an inhalation vapour in liquid form. The dosage is set at 3% and the route of administration is through inhalation.

The comparator treatment is propofol, provided as an emulsion for injection/infusion. The dosage is 12 mg/kg/h, administered via intravenous injection or intravenous infusion.

The efficacy of anesthetic maintenance in patients with acute ischemic stroke undergoing mechanical thrombectomy will be evaluated using the final infarct volume as the primary outcome. This parameter will be assessed via magnetic resonance imaging using the fluid-attenuated inversion recovery sequence. Measurements are scheduled for follow-up at 72 hours post-treatment, with a permissible window of ± 24 hours.