Determining and comparing the therapeutic effect of intratempanic injection of triamcinolone and dexamethasone in patients with sudden sensorineural hearing loss
Design
The clinical trial has a control group, with parallel groups, double-blind, randomized, phase 3 on 62 patients. Blocks of four are used for randomization.
Settings and conduct
The statistical population includes patients referred to Imam Khomeini Hospital who suffer from sudden sensorineural hearing loss with hearing loss of more than 30 dB in three consecutive frequencies in less than three days in audiometry, which are randomly divided into intervention and control group. Intratympanic injection of triamcinolone will be given to the intervention group and intratympanic injection of dexamethasone will be given to the control group. The study was double-blind and participants and the audiologist evaluating the audiometry were kept blind from being assigned to the study groups
Participants/Inclusion and exclusion criteria
Patients will be included in the study who have contraindications to receiving systemic corticosteroids such as uncontrolled diabetes, hematologic malignancies, etc.
Intervention groups
The intervention group will be injected with intratympanic triamcinolone ampule and the control group will be injected with intratympanic dexamethasone ampule.
Main outcome variables
Hearing improvement based on audiometry .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171004036554N4
Registration date:2021-12-18, 1400/09/27
Registration timing:prospective
Last update:2021-12-18, 1400/09/27
Update count:0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Hamed Emami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2393
Email address
h_emami@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effects of intratympanic injections of Triamcinolon and Dexametason who suffer from sudden sensorineural hearing loss
Public title
Comparison of the therapeutic effects of intratympanic injections of Triamcinolon and Dexametasone who suffer from sudden sensorineural hearing loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with SSNH diagnosis who are candidates for intratympanic injection
Patients who have a contraindication to receive systemic corticosteroids, such as underlying diseases like diabetes or defective immune disorders .
Patients who are interested in receiving intra tympanic corticosteroids instead of systemic corticosteroids .
Exclusion criteria:
Patients who are candidates for receive systemic corticosteroids
Patients who are not volunteer to receive intratympanic corticosteroids
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
we use block randomization. we have blocks of four intervention (A) and four of control (B) groups and write them from 1-6 on cards and put them in a pocket, then choose them by chance and make a sequence of cards. We import patients of interventional or control group of our study from these sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient's consent states that the injection is done randomly with one of these drugs and the patient is unaware of the contents of the drug syringe. Also, the person who evaluates the patients' audiometry after the injection is unaware of which group the patient belongs to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Amiralam Hospital
Street address
Saadi Avenue, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1981613875
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1400.048
Health conditions studied
1
Description of health condition studied
Sudden sensorineural hearing loss
ICD-10 code
H91.23
ICD-10 code description
Sudden idiopathic hearing loss, bilateral
Primary outcomes
1
Description
Hearing improvement based on audiometry
Timepoint
Complete response to treatment refers to an increase of 30 dB after 15 to 45 days after IT injection of dexamethasone and triamcinolone. The relative response to treatment refers to an increase of 10 dB 15 to 45 days after IT injection of dexamethasone. An improvement of less than 10 decibels will be considered as no response or failure of treatment
Method of measurement
Based on audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, using Triamcinolone ampoule 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek.
Category
Treatment - Drugs
2
Description
Control group: In the intervention group, using Dexamethasone 0.4-0.6 cc for Intratympanic injection that performed 6 injections twice aweek.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Otorhynolaryngology clinic of Imam Khomeini hospital complex
Full name of responsible person
Hamed Emami
Street address
Imam Khomeini hospital complex , Bagherkhan Ave, South Chamran highway
City
Tehran
Province
Tehran
Postal code
1981613875
Phone
+98 21 6658 1628
Email
hd_ememi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Qods Ave, Keshavarz Blv,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 9664
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saleh Habibi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
141765371
Phone
0098 21 61190
Email
s.habibi@Gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
141765371
Phone
0098 21 61190
Email
hd_emami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saleh Habibi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
141765371
Phone
0098 21 61190
Email
s.habibi@Gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available