Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery
Primary Purpose
Facial Palsy
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
methylprednisolone
Sponsored by
About this trial
This is an interventional prevention trial for Facial Palsy focused on measuring Facial palsy, Vestibular schwannoma, Anti-inflammatory drugs, Post surgery of vestibular schwannoma, or of cranial base tumors
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hopitaux de Paris
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
2
1
Arm Description
placebo versus methylprednisolone
placebo versus methylprednisolone
Outcomes
Primary Outcome Measures
Assessment of the facial function at 8 days postoperative
Secondary Outcome Measures
Assessment of the facial function at 1 day postoperative
Full Information
NCT ID
NCT00438087
First Posted
February 9, 2007
Last Updated
July 6, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00438087
Brief Title
Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery
Official Title
Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Palsy
Keywords
Facial palsy, Vestibular schwannoma, Anti-inflammatory drugs, Post surgery of vestibular schwannoma, or of cranial base tumors
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
313 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo versus methylprednisolone
Arm Title
1
Arm Type
Experimental
Arm Description
placebo versus methylprednisolone
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
methylprednisolone administrated intra and post operatively
Intervention Description
methylprednisolone administrated intra and post operatively
Primary Outcome Measure Information:
Title
Assessment of the facial function at 8 days postoperative
Time Frame
at 8 days postoperative
Secondary Outcome Measure Information:
Title
Assessment of the facial function at 1 day postoperative
Time Frame
at 1 day postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis BOZORG GRAYELI, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Paris
City
Clichy
Country
France
12. IPD Sharing Statement
Learn more about this trial
Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery
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