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IRCT20221114056502N1 IRCT 2023-01-01 Shahid Beheshti University of Medical Sciences 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 2023-01-21 anticipated 35 Complete https://irct.ir/trial/66851 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Otosclerosis. Intervention 1: Intervention group: in the intervention group patients undergo stapedectomy surgery before implanting the prosthesis 4 drops of dexamethasone are poured into the base of the steps bone and the oval window. Intervention 2: Control group: in the control group instead of dexamethasone a few drops of normal saline are poured into the base of the steps bone and the oval window and then the prosthesis is going to get inserted. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more informations
public Behrouz Barati
ENT department- Taleghani hospital- A'rabi street, Yaman street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 913 323 5343 b_barati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Behrouz Barati
ENT department- Taleghani hospital- A'rabi street, Yaman street, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 913 323 5343 b_barati@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of otosclerosis based on audiometry, familial history, air-bone gap more than 20 decibel in 0.5, 1, 2, 3 kilohertz, absens of anomaly and timpano membrane perforation Age older than 18 y/o Have surgery indications 18 years no limit Both Sensitivity to corticosteroids Patients with asthma Patients with hypertension No referrals patients for primary and secondary evaluations History of middle ear surgery H80 Otosclerosis Treatment - Drugs Placebo Intervention group: in the intervention group patients undergo stapedectomy surgery before implanting the prosthesis 4 drops of dexamethasone are poured into the base of the steps bone and the oval window. Control group: in the control group instead of dexamethasone a few drops of normal saline are poured into the base of the steps bone and the oval window and then the prosthesis is going to get inserted. Reducing vertigo after surgery. Timepoint: At time of discharge - 4 week after operation. Method of measurement: Vertigo disability questionnaire - Audiometry. Shahid Beheshti University of Medical Sciences Approved 2022-10-18 Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences ENT academia-Taleghany hospital-Tehran_Iran Tehran Tehran Iran (Islamic Republic of)