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Clinical Trials/jRCTs041200042
jRCTs041200042CompletedNot Applicable

Effect of intratympanic dexamethasone pretreatment on facial neve decompression surgery

Not provided0 sites12 target enrollmentStarted: October 20, 2020Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Primary Endpoint
-

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized Controlled Trial
Intervention Model
Parallel Assignment
Primary Purpose
Treatment Purpose
Masking
Double Blind

Eligibility Criteria

Ages
20age old over to No limit (—)
Sex
All

Inclusion Criteria

  • 1.Diagnosis as peripheral facial nerve palsy at Department of Otolaryngology-Head and Neck, Nagoya City University Hospital.
  • 2.Diagnosis as a severe facial palsy of <=8 points of Yanagihara scoring system.
  • 3.<=10% Electroneurography value.
  • 4.Candidate of facial nerve decompression
  • 5.>=20 years old who can give consent in writing.

Exclusion Criteria

  • 1.Presence of nonviral inflammation in the middle ear
  • 2.Presence of bacterial disease at carriage state.
  • 3.Presence of middle ear or inner ear anomaly that would make injection into middle ear impossible.
  • 4.Glycated hemoglobin >=6.5%.
  • 5.Creatinine clearance <=50 ml/min
  • 6.Alanine transaminase >=100 U/l or aspartate transaminase >=100 U/l.
  • 7.Severely protracted wound healing.
  • 8.Signs of central facial palsy or other neurological disease that could potentially affect facial function
  • 9.Pregnancy or possible pregnancy
  • 10.Participation in other clinical trials within 3 months
  • 11.History of dexamethasone treatment within 2 weeks
  • 12.Recurrent facial palsy
  • 13.Unable to properly conduct pure tone audiometry test, pitch match test, roundness balance test or tinnitus handicap inventory test.
  • 14.Inappropriate for participation in the trial in the opinion of the investigators.

Outcomes

Primary Outcomes

-

Hearing threshold on pure tone audiogram

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not provided

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