Effect of Stellate Ganglion Block on Meniere's Disease

Study Overview
=================
Brief Summary
-----------------
Stellate ganglion block (SGB) has been the alternative treatment of Meniere's disease for years. However, objective evidence of the effect of SGB was still lack. The investigators conducted a randomized controlled study to examine the immediate effects of SGB in SP/AP of electrocochleography (ECoG).

Detailed Description
-----------------
Ten patients were randomly assigned to receive stellate ganglion block. These ten patients made up the experimental group. Another ten patients in the control group were assigned to receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Official Title
-----------------
Effect of Stellate Ganglion Block on Meniere's Disease

Conditions
-----------------
Vertigo, Meniere Disease

Intervention / Treatment
-----------------
* Procedure: stellate ganglion block
* Drug: 0.25mg, fludiazine
* Drug: 25mg cephadol@ (diphenidol)
* Drug: 200mg kentons@ (tocopherol nicotinate).


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995) Exclusion Criteria: patients with coagulopathy, arrhythmia, myocardial ischemia, glaucoma, pregnant, chronic otitis media or externa, and past history of middle or inner ear surgery were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate ganglion block<br>treated with SGB | Procedure: stellate ganglion block<br>* stellate ganglion block<br>|
| Active Comparator: Oral medication<br>treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate). | Drug: 0.25mg, fludiazine<br>* 0.25mg of erispan@ (fludiazine), p.o. one dose only.<br>* Other names: 0.25mg of erispan@;Drug: 25mg cephadol@ (diphenidol)<br>* 25mg cephadol@ (diphenidol) p.o. one dose only.<br>Drug: 200mg kentons@ (tocopherol nicotinate).<br>* 200mg kentons@ (tocopherol nicotinate) p.o. one dose only.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SP/AP of Electrocochleography | SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment | ECoG was reorded 2 hours after SGB | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SP/AP recorded at 4 hours after SGB | SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB | 4 hours after SGB | 
| SP/AP recorded at 6 hours after SGB | SP/AP recorded at 4 hours after SGB was compared with the SP/AP recorded before SGB | 6 hours after SGB | 
| scores of verbal scale for vertigo recorded at 6 hours after SGB | scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB | 6 hours after SGB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stellate ganglion block., Meniere's disease., electrocochleography., vertigo., hearing impairment.