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The purpose of this study is to evaluate the efficacy and safety of steroids treatment compared with placebo in preserving facial nerve function after craniotomy in patients with vestibular schwannoma who have not received preoperative treatment and have good intraoperative facial nerve function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroids Group | Experimental | Methylprednisolone sodium succinate (80 mg/day) on days 1-3 post-surgery, followed by prednisone acetate (20 mg/day) on days 4-10. |
|
| Placebo Group | Placebo Comparator | Methylprednisolone sodium succinate placebo on days 1-3 post-surgery, followed by prednisone acetate placebo on days 4-10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroids therapy | Drug | Methylprednisolone sodium succinate 80 mg powder dissolved in 100 mL of sodium chloride solution (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery | Defined as House-Brackmann grade I or II. | at 90 (±7) days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery | Defined as House-Brackmann grade I or II. | at 10 days after surgery |
| Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Jia, PhD | Contact | 8615510033866 | jwttyy@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| D020330 | Bell Palsy |
| D005158 | Facial Paralysis |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients with untreated unilateral vestibular schwannoma and good preoperative facial nerve function will be randomized in a 1:1 ratio to receive either steroid therapy or placebo. All participants will undergo craniotomy with intraoperative neurophysiological monitoring to ensure adequate facial nerve function preservation. Treatment will be initiated on the day of surgery and continued for 10 days. The primary outcome is the proportion of patients with good facial nerve recovery at 90 days postoperatively.
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This study adopted a double-blind design. Study drugs and placebos are identically packaged. The dosage form, size, color, weight, smell, and taste of the placebo were basically similar to those of the research drug, and there was no risk of blinding. Personnel involved in randomization or potentially exposed to treatment allocation (including pharmacy staff) are not involved in patient care, outcome assessment, or data analysis. Blinded investigators and outcome assessors remain unaware of treatment assignments throughout the study.
| Placebo | Drug | Methylprednisolone sodium succinate placebo powder dissolved in 100 mL of sodium chloride solution (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. |
|
Defined as House-Brackmann grade I
| at 90 (±7) days after surgery |
| Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery | Defined as House-Brackmann grade I | at 10 days after surgery |
| Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery | Sunnybrook Facial Grading System will be used. Score of 100 represents complete recovery. | at 90 (±7) days after surgery |
| Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery | Sunnybrook Facial Grading System will be used. Score of 100 represents complete recovery. | at 10 days after surgery |
| Adverse events within 90 days | Within 90 (±7) days after surgery |
| Serious adverse events within 90 days | Within 90 (±7) days after surgery |
| Adverse events within 10 days | Within 10 days after surgery |
| Serious adverse events within 10 days | Within 10 days after surgery |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |