Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery

July 6, 2012 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Material and Methods: A multi center, prospective, randomized, versus placebo, and double-blind study will be undertaken. Four-hundred patients undergoing surgery for a cerebellopontine angle tumor will be included during 23 months. Three university departments of otolaryngology (Hospital BEAUJON, CHU de Bordeaux, CHU de Tours) will participate. The pre operative assessment includes a clinical examination with the assessment of the facial function (in 6 grades according to House and BRACKMANN), an audiometry and a vestibular testing, and a cranial MRI with the classification of tumors in 4 stages according to their size. Patients will be randomized after information and with their consent. During surgery, the degree of nerve stretch (4 stages), the tumor adhesion to the nerve (4 stages) and the stimulation thresholds of the facial nerve with an electromyographic monitoring device (NIM Response 2, XOMED MEDTRONICS, Jacksonville, FL) will be recorded. All cases of facial nerve interruption during surgery will be excluded. In the treated group, one IV injection of methyl prednisolone at 1 mg/kg/day will be administered intra operatively and on postoperative days 1 and 2. The treatment will be continued on days 3 to 7 with the same dosage orally. Subsequently, 0.5 mg/kg/day at days 8 and 8, and 0.25 mg/kg/day at days 10 and 11. The facial function will be assessed on postoperative days 1, 8 and 30 clinically.

Expected results: Considering the effect of corticosteroids in the idiopathic facial palsy and the effect of these agents on edema and inflammation, we expect and decrease in the incidence of immediate and delayed postoperative facial palsies. The intra operative stimulation thresholds may indicate a subgroup of patients for which the efficiency of the corticosteroids is higher than in the whole series.

Conclusion : The facial palsy after surgery of cerebellopontine angle tumors is the most frequent and the most significant morbidity. Corticosteroids may decrease the incidence of this complication.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France
        • Assistance Publique Hopitaux De Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
placebo versus methylprednisolone
Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
Other Names:
  • methylprednisolone administrated intra and post operatively
EXPERIMENTAL: 1
placebo versus methylprednisolone
Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
Other Names:
  • methylprednisolone administrated intra and post operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the facial function at 8 days postoperative
Time Frame: at 8 days postoperative
at 8 days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the facial function at 1 day postoperative
Time Frame: at 1 day postoperative
at 1 day postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Alexis BOZORG GRAYELI, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (ESTIMATE)

February 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P051072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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