Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients

Vestibular schwannoma (VS) is a benign tumor arising from the vestibular nerve. Surgical resection is a common treatment, and intraoperative neurophysiological monitoring (IONM) is widely used to protect facial nerve function. However, postoperative facial nerve paralysis remains a common complication, affecting patients' appearance, confidence, and quality of life.

Steroids are often used to reduce inflammation and edema in idiopathic facial palsy, but their efficacy and safety in post-surgical VS patients remain uncertain. The mechanism of post-surgical facial nerve dysfunction is more complex than idiopathic palsy and may involve physical traction, vascular compromise, or inflammatory injury.

This study (SAF-NRVS) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients aged 18 to 60 years with a clinically confirmed untreated unilateral vestibular schwannoma will be enrolled. Eligible patients must have no preoperative facial paralysis (grade I according to the House-Brackmann grading system), and have good intraoperative facial nerve function as determined by intraoperative neurophysiological monitoring. Participants will be randomly divided into two groups in a 1:1 ratio. Intervention group (Steroids group) will receive 80 mg of methylprednisolone sodium succinate powder dissolved in 100 ml of sodium chloride (NaCl) solution by intravenous infusion once daily from the day of surgery to day 3, followed by 20 mg of prednisone acetate oral intake once daily from day 4 to day 10. Control group (Placebo group) will receive methylprednisolone sodium succinate placebo powder dissolved in 100 ml of NaCl solution by intravenous infusion once daily from the day of surgery to day 3, followed by prednisone acetate placebo oral intake once daily from day 4 to day 10. The primary outcome measure is the proportion of patients with good facial nerve function recovery at 90 days after surgery, defined as grade 1 or 2 according to House-Brackmann grading system.

• Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery [Срок оценки: at 10 days after surgery]
• Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery [Срок оценки: at 90 (±7) days after surgery]
• Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery [Срок оценки: at 10 days after surgery]
• Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery [Срок оценки: at 90 (±7) days after surgery]
• Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery [Срок оценки: at 10 days after surgery]
• Adverse events within 90 days [Срок оценки: Within 90 (±7) days after surgery]
• Serious adverse events within 90 days [Срок оценки: Within 90 (±7) days after surgery]
• Adverse events within 10 days [Срок оценки: Within 10 days after surgery]
• Serious adverse events within 10 days [Срок оценки: Within 10 days after surgery]