Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation
Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.
In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | Cochlear Implantation |
|
| Dexamethasone | Active Comparator | Cochlear implantation using topical dexamethasone |
|
| Dexamethasone+Hyaluronic acid | Active Comparator | Cochlear implantation using topical dexamethasone associated with hyaluronic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear Implantation | Device | Cochlear implantation using Hybrid L24 Implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hearing thresholds | Hearing thresholds will be measured by audiometry in the frequencies 125, 250, 500, 1000, 2000 and 4000 Hz in the preoperatory, 1 month, 3 months and 6 months after the surgery. | within the first 6 months after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernardo F Ramos | University of São Paulo General Hospital | Principal Investigator |
| Rubens V Brito Neto | University of São Paulo General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo General Hospital | São Paulo | São Paulo | Brazil |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| D003907 | Dexamethasone |
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cochlear Implantation+dexamethasone | Drug | Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window |
|
|
| Cochlear Implantation+dexamethasone+hyaluronic acid | Drug | Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array |
|
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |