Evaluation of the effect of adding corticosteroids in the middle ear before Embedding implant in surgery of otosclerosis patients on reducing postoperative vertigo

Evaluation of the effect of adding corticosteroids in the middle ear before embedding implant in surgery of otosclerosis patients on reducing postoperative vertigo

Clinical trial with control group, parallel, double blinded, randomized, 3rd phase on 35 patients, random blocks were used for randomization.

This clinical trial between 2022-2024 occur on the patient with hearing reduction and have positive history of otosclerosis in family evaluations and have hearing loss 2k in audiogram and have high risk of otosclerosis and surgery indication.

Inclusion criteria: diagnosis otosclerosis based on audiometry; familial history; air bone gap 20 decibel in 0.5, 1, 2, 3 kilohertz without any anomaly and timpano membrane perforation; age over 18 years old; have indication for surgery. Exclusion criteria: sensitivity to corticosteroids; patients with asthma; patients with hypertension; no referral for primary and secondary evaluations; history of middle ear surgery.

Patients who undergone stapedectomy before insertion of implant 4 drops of dexamethasone use on stapes osteon and oval window and in the control group normal saline use instead of corticosteroid at the same place and then implant insert

Hospital stay; hearing reducing; vertigo severity

The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre- and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 35, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope.

Both patients and clinicians are blinded in this study. drug and placebo use in the similar pack with label of A or B. At the beginning of procedure, the clinicians write the label of drug and the top of the questioner.