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Effect of intratympanic dexamethasone pretreatment on facial neve decompression surgery

Study on intratympanic steroid therapy on facial nerve decompression surgery

8

Four males and four females were regstered in this study. Two patients had Bell's palsy, and the other 6 had Ramsay Hunt syndrome.

Not applicable

No complication or adverse event was reported.

As the primary endpoint, we intended to demonstrate the effectiveness on postoperative tinnitus. However, due to the insufficient sample numbers, both primary and secondary endpoints were unable to subject to an appropriate statistical analysis.

Due to the insufficient sample numbers, 3 in intervention and 5 in control group, statistica analysis was unable to perform following the routine statistical procedure.

Oct. 01, 2023

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs041200042

Inagaki Akira

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

ainagaki@med.nagoya-cu.ac.jp

Inagaki Akira

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-853-8256

ainagaki@med.nagoya-cu.ac.jp

Complete

Sept. 02, 2020

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

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.

Both

Peripheral facial nerve palsy

Intratympanic steroid therapy

Facial palsy, intratympanic injection, steroid therapy

039

Hearing threshold on pure tone audiogram

Pitchmatch test, loudness balance test, tinnitus handicap inventory,facial perineurium fluid and serum dexamethasone concentration, residual tympanic perforation

+81-52-858-7215

Aug. 17, 2020

None