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Corticosteroids in Prevention of Facial Palsy After Cranial Base Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438087
First Posted: February 21, 2007
Last Update Posted: July 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
Facial palsy after surgical removal of cranial base tumors adherent to the nerve can partly be explained by inflammation.

Condition Intervention Phase
Facial Palsy Drug: methylprednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Assessment of Corticosteroid Effect in the Prevention of Facial Palsy After Cerebella-pontine Angle Surgery

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Assessment of the facial function at 8 days postoperative [ Time Frame: at 8 days postoperative ]

Secondary Outcome Measures:
  • Assessment of the facial function at 1 day postoperative [ Time Frame: at 1 day postoperative ]

Enrollment: 313
Study Start Date: March 2007
Study Completion Date: January 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
placebo versus methylprednisolone
Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
Other Name: methylprednisolone administrated intra and post operatively
Experimental: 1
placebo versus methylprednisolone
Drug: methylprednisolone
methylprednisolone administrated intra and post operatively
Other Name: methylprednisolone administrated intra and post operatively

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438087


Locations
France
Assistance Publique Hopitaux de Paris
Clichy, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alexis BOZORG GRAYELI, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00438087     History of Changes
Other Study ID Numbers: P051072
First Submitted: February 9, 2007
First Posted: February 21, 2007
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Facial palsy
Vestibular schwannoma
Anti-inflammatory drugs
Post surgery of vestibular schwannoma
or of cranial base tumors

Additional relevant MeSH terms:
Paralysis
Facies
Facial Paralysis
Bell Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Disease Attributes
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids