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IRCT20211125053181N2 IRCT 2023-11-11 Esfahan University of Medical Sciences Effect of Intratympanic injection of dexamethasone via catheter in Sudden Sensory Neural Hearing Loss SSNHL Effect of Intratympanic injection of dexamethasone via catheter in Sudden Sensory Neural Hearing Loss (SSNHL) 2023-12-05 anticipated 60 Complete https://irct.ir/trial/72964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: For treat sudden-onset sensorineural hearing loss by using a catheter, previous researchers had used very invasive methods, which was to create a subcutaneous tunnel in the ear canal and pass the catheter through the Middle ear, which is an invasive method. In our method, as simple as VT surgery, first myringotomy is performed and by measuring the appropriate length of the catheter, the end of the catheter is inserted into the middle ear, and the end of the catheter that exits the ear canal is stitched to the skin at several points, which minimized catheter mobility and therefore this method is less invasive in the ear canal and can be performed technically by any otolaryngologist, Randomization description: Random allocation method is used In this way, the total size of the sample is determined and the set of group A and group B is randomly defined. Patients are entered randomly in the group by lottery. Random allocation software is used to speed up the work, Blinding description: The treatment methods are explained to the patient and the patient is aware of his treatment group, so there is no possibility of blinding the study for the patient. For this reason, blinding is done only for the outcome evaluator and data analyst. The data are in the form of audiometry results, so the outcome evaluator and the analyst are not in contact with the patient and do not know the patient's treatment group. N/A Sudden Sensory-Neural Hearing Loss (SSNHL). Intervention 1: Intervention group: Patients with severe sudden hearing loss in the catheter injection group. In these patients, under local anesthesia of the ear canal, a tympanotomy will perform in the posterior inferior of the tympanic membrane and the catheter will be measure and the end of the catheter will place in the myringotomy site as in the VT operation, and the outer end of the catheter will be sutured to the upper part of the auricle at the level of helix junction and the rest of catheter is fixed behind the patient's ear. A gray feeding tube catheter will be used for patients. During two weeks, the patient will undergo two injection per day, and inject two milligrams of dexamethasone slowly with a needle-free insulin syringe at the catheter, and the infusion will be done by a assistant who collaborates with the study. The patients will followed up for three months and immediately after the completion of the treatment, two weeks later, one month later and three months later, hearing evaluation is done for the patients and the results are recorded. Intervention 2: Control group: For patients with severe Sudden Sensorineural hearing loss who are in the classic ear injection group, dexamethasone injection will be performed every other day using spinal needle number 25. At least four injections are given to the patient during an eight-day period. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Start the access period immediately after printing the results To whom: For researchers working in academic and scientific institutions and researchers in industrial centers Conditions: Analysis with reference to the data source is allowed Where to obtain: Dr. Mohammad Shahab Akhavan dr.m.shahab.akhavan@gmail.com 09103986427 How to obtain: ontact the researcher and announce the email, receive the documents by email after a maximum of one week Comments:
public Sohrab Rabiei
Ayatollah Kashani Street, Office of Ear Throat Nose and Head and Neck Surgery
isfahan Iran (Islamic Republic of) 8343481839 +98 31 3629 0410 sohrabrabiei@gmail.com Esfahan University of Medical Sciences scientific Sohrab Rabiei
Ayatollah Kashani Street, Office of Ear Throat Nose and Head and Neck Surgery
isfahan Iran (Islamic Republic of) 8343481839 0098 32 36290410 sohrabrabiei@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adult age (18-75 age old) Hearing loss greater than 60db based on SRT In the first two weeks of the disease 18 years 75 years Both Lack of consent for treatment at any stage Presence of active infectious ear disease Referral more than a month after the onset of the disease Presence of other causes of hearing loss (ear tumor, toxic drugs, sound trauma, ear surgery) H91.20 Sudden idiopathic hearing loss, unspecified ear Treatment - Drugs Treatment - Drugs Intervention group: Patients with severe sudden hearing loss in the catheter injection group. In these patients, under local anesthesia of the ear canal, a tympanotomy will perform in the posterior inferior of the tympanic membrane and the catheter will be measure and the end of the catheter will place in the myringotomy site as in the VT operation, and the outer end of the catheter will be sutured to the upper part of the auricle at the level of helix junction and the rest of catheter is fixed behind the patient's ear. A gray feeding tube catheter will be used for patients. During two weeks, the patient will undergo two injection per day, and inject two milligrams of dexamethasone slowly with a needle-free insulin syringe at the catheter, and the infusion will be done by a assistant who collaborates with the study. The patients will followed up for three months and immediately after the completion of the treatment, two weeks later, one month later and three months later, hearing evaluation is done for the patients and the results are recorded. Control group: For patients with severe Sudden Sensorineural hearing loss who are in the classic ear injection group, dexamethasone injection will be performed every other day using spinal needle number 25. At least four injections are given to the patient during an eight-day period. Hearing threshold pure tone (PTA) and speech reception threshold (SRT) in the initial audiometry and then their changes in the follow-up period. Timepoint: At the beginning of the study and 14, 30, 90 days after the start of treatment. Method of measurement: Pure tone audiometry (PTA) and assessment of changes in speech perception threshold (SRT) before and after treatment. Esfahan University of Medical Sciences Approved 2023-05-24 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences No. 110, Nik Nafs Alley, Vahid St., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)