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临床试验/NCT00438087
NCT00438087已完成3 期

Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
313
试验地点
1
主要终点
Assessment of the facial function at 8 days postoperative

研究概览

简要总结

Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.

详细描述

Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.

The purpose of this study was to assess the efficiency of corticosteroids to prevent facial palsy after such surgery and to identify the patients that will have the highest benefit from an anti-inflammatory treatment.

This study will include patients undergoing surgery for a benign tumor of the cranial base (vestibular schwannoma). The efficiency of high dosage corticosteroids administered intravenously during and after surgery will be evaluated on the facial nerve function in comparison to a placebo. Pre operative and intra operative data will be collected and analysed in order to investigate possible predictive factors of response to the treatment.

Introduction: After the surgical removal of a cerebella-pontine angle tumor (mainly vestibular schwannoma), and despite the anatomical integrity of the facial nerve, an immediate or delayed facial palsy may occur. This palsy may be explained by ischemia, edema, inflammation, or a neurotmesis (ruptured axons in an intact nerve sheet). This phenomenon is highly dependent on the size of the tumor. In our preliminary studies, we observed an immediate facial palsy in 16% and a palsy occurring at postoperative day 8 in 23% of the patients operated on for a vestibular schwannoma. Corticosteroids may decrease the inflammation and the edema around the nerve and reduce the incidence of the postoperative facial palsy. Their efficiency has already been demonstrated in idiopathic facial palsy. In a previously published study , a single dose of dexamethasone during surgery did not influence the facial function outcome. But the short period of the treatment do not allow definitive conclusions.

Objectives: The aim of this study is to analyze the effect of a corticosteroid (methyl prednisolone) administered intra- and postoperatively on the incidence of facial palsy after surgery of cerebella-pontine angle tumors and to determine intra operative prognostic factors for the facial function outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adults patients
  • surgery of base crane tumors
  • accept to participate
  • having health insurance

排除标准

  • pregnant woman
  • known allergy to steroids
  • preoperative facial palsy of grade >2

研究组 & 干预措施

2

Placebo Comparator

placebo versus methylprednisolone

干预措施: methylprednisolone (Drug)

1

Experimental

placebo versus methylprednisolone

干预措施: methylprednisolone (Drug)

结局指标

主要结局

Assessment of the facial function at 8 days postoperative

时间窗: at 8 days postoperative

次要结局

  • Assessment of the facial function at 1 day postoperative(at 1 day postoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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