]>
IRCT20220307054210N1 IRCT 2023-04-05 Kerman University of Medical Sciences The efficacy of intratympanic injection of nanogel dexamethasone in Sudden Sensorineural Hearing Loss (SSNHL) treatment, The effectiveness of intratympanic injection of nanogel dexamethasone versus non-nanogel dexamethasone in treatment of patients with Sudden Sensorineural Hearing Loss (SSNHL), a double blind clinical trial 2022-03-26 anticipated 90 Complete https://irct.ir/trial/62962 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In order to make blind the researcher and the interpreter, the concentrated form of dexamethasone (nanogel)and the usual form of dexamethasone were prepared by a nanopharmacologist and presented to the researcher in containers of the same shape with specific numbers. We did not have the power to distinguish the control group from intervention group.Only the manufacturer of the concentrated solution had the information about which drug each container number corresponded to. And the patients in both groups received intratympanic injection treatment and oral medication, which were similar, and the patient did not know whether he was in the control or intervention group. 3 Sudden Sensorineural Hearing Loss. Intervention 1: Control group: Patients in this group will receive oral prednisolone at a dose of 1 mg per kg to a maximum of 60 mg daily for 14 days. Intervention 2: Intervention group: for patients of this group, 4 doses of 20 mg nano-gel form of dexamethasone ampule will be injected into the posterior-inferior quadrant of the tympanic membrane by the pink angiocatheter (20 G) with the patient's head rotated 45 degrees to the other side. The injection will be performed under a microscope, and the success of the injection will depend on the observation of the tympanic membrane protruding from the fluid injected into the middle ear; If unsuccessful, re-injection will be given with less dexamethasone. This operation will be performed 4 times during an 8-day period every other day. Each patient will also receive oral prednisolone at a dose of 1 mg per kg for a maximum of 60 mg daily for 14 days. Yes - There is a plan to make this available What will be shared: Data can be shared after deidentifying people. The specific titles of the documents include the demographic characteristics of the people participating in the study and the data obtained from the audiometry of the patients including pta and srt before and after the intervention and qualitative data such as dizziness and tinnitus and can be shared. . When: Access to data is possible 6 months after publishing the results. To whom: The data of this study will be available only to professionals working in academic and scientific institutions. Conditions: I do not have special conditions for access and use of data by others. Where to obtain: Data applicants can access the data by sending a request through my email or mobile phone. fereshtehfa@ymail.com 09158671902 How to obtain: It does not go through a special process and the data will be sent to them as soon as the request is received. Comments:
public Fereshteh Fazlinezhad
Shafa Hospital, Kowsar Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) ۷۶۱۸۷۵۱۱۵۱ +98 56 3246 1031 ffazlinejad@kmu.ac.ir Kerman University of Medical Sciences scientific Fereshteh Fazlinezhad
Shafa Hospital, Kowsar Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) ۷۶۱۸۷۵۱۱۵۱ +98 56 3246 1031 ffazlinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) One-way SSNHL at 30 dB at three consecutive frequencies generated in 72 hours or less The time period from the time of hearing loss until the patient is admitted to the hospital for the procedure is less than or equal to 45 days no limit no limit Both Evidence of otitis media on examination and history Known history of ear anomaleis Evidence of retrocuclear disease, history of meniere's disease history of acoustic trauma history of immunodeficiency history of sudden sensory neural hearing loss with other known couses history of heart disease H91.20 Sudden idiopathic hearing loss, unspecified ear Treatment - Drugs Treatment - Drugs Control group: Patients in this group will receive oral prednisolone at a dose of 1 mg per kg to a maximum of 60 mg daily for 14 days. Intervention group: for patients of this group, 4 doses of 20 mg nano-gel form of dexamethasone ampule will be injected into the posterior-inferior quadrant of the tympanic membrane by the pink angiocatheter (20 G) with the patient's head rotated 45 degrees to the other side. The injection will be performed under a microscope, and the success of the injection will depend on the observation of the tympanic membrane protruding from the fluid injected into the middle ear; If unsuccessful, re-injection will be given with less dexamethasone. This operation will be performed 4 times during an 8-day period every other day. Each patient will also receive oral prednisolone at a dose of 1 mg per kg for a maximum of 60 mg daily for 14 days. Hearing level. Timepoint: Measurement of the patient's hearing level at the beginning of the study (before the intervention) and 2 weeks after and 2 months after the start of the treatment period. Method of measurement: The hearing level was measured with audiometric criteria (PTA and srt) using an audiogram. Vertigo. Timepoint: Vertigo was examined before the start of treatment and 2 weeks and 2 months after the start of treatment. Method of measurement: Dizziness was investigated using a questionnaire. Tinnitus. Timepoint: tinnitus was examined before the start of treatment and 2 weeks and 2 months after the start of treatment. Method of measurement: tinnitus was investigated using a questionnaire. SRT :(speech recognition threshold). Timepoint: before intervention and 2 and 4 weeks after intervention. Method of measurement: audiometry. PTA:( pure tone audiometry). Timepoint: before intervention and 2 and 4 weeks after intervention. Method of measurement: audiometry. Kerman University of Medical Sciences Approved 2022-10-23 Research Ethics Committees of Afzalipour Hospital- Kerman University of Medical Sciences Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center kerman Kerman Iran (Islamic Republic of)