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Effect of Stellate Ganglion Block on Meniere's Disease
This study has been completed.
Sponsor:
Chi Mei Medical Hospital
Information provided by (Responsible Party):
Yung-Song Lin, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier:
NCT01574313
First received: April 1, 2012
Last updated: April 10, 2012
Last verified: April 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
| Vertigo Meniere Disease | Procedure: stellate ganglion block Drug: 0.25mg, fludiazine Drug: 25mg cephadol@ (diphenidol) Drug: 200mg kentons@ (tocopherol nicotinate). | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Stellate Ganglion Block on Meniere's Disease |
Resource links provided by NLM:
Further study details as provided by Yung-Song Lin, Chi Mei Medical Hospital:
Primary Outcome Measures:
- SP/AP of Electrocochleography [ Time Frame: ECoG was reorded 2 hours after SGB ]SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment
Secondary Outcome Measures:
- SP/AP recorded at 4 hours after SGB [ Time Frame: 4 hours after SGB ]SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB
- SP/AP recorded at 6 hours after SGB [ Time Frame: 6 hours after SGB ]SP/AP recorded at 4 hours after SGB was compared with the SP/AP recorded before SGB
- scores of verbal scale for vertigo recorded at 6 hours after SGB [ Time Frame: 6 hours after SGB ]scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB
| Enrollment: | 20 |
| Study Start Date: | April 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stellate ganglion block
treated with SGB
|
Procedure: stellate ganglion block
stellate ganglion block
|
|
Active Comparator: Oral medication
treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
|
Drug: 0.25mg, fludiazine
0.25mg of erispan@ (fludiazine), p.o. one dose only.
Other Name: 0.25mg of erispan@
Drug: 25mg cephadol@ (diphenidol)
25mg cephadol@ (diphenidol) p.o. one dose only.
Drug: 200mg kentons@ (tocopherol nicotinate).
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
|
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).
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01574313
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574313
Locations
| Taiwan | |
| i Mei Medical Center Tainan, Taiwan, Taiwan | |
| Tainan, Taiwan, 70014 | |
Sponsors and Collaborators
Chi Mei Medical Hospital
Investigators
| Principal Investigator: | Yung-Song Lin, M.D. | Chi Mei Medical Hospital |
More Information
| Responsible Party: | Yung-Song Lin, Chairman of department of Otolaryngology, Chi Mei Medical Hospital |
| ClinicalTrials.gov Identifier: | NCT01574313 History of Changes |
| Other Study ID Numbers: |
SGB09804-003 CMH09804-003 ( Other Grant/Funding Number: Chi Mei Medical Center, Taiwan ) |
| Study First Received: | April 1, 2012 |
| Last Updated: | April 10, 2012 |
Keywords provided by Yung-Song Lin, Chi Mei Medical Hospital:
|
stellate ganglion block. Meniere's disease. electrocochleography. vertigo. hearing impairment. |
Additional relevant MeSH terms:
|
Meniere Disease Ganglion Cysts Synovial Cyst Vertigo Dizziness Cysts Neoplasms Mucinoses Connective Tissue Diseases Endolymphatic Hydrops Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Vestibular Diseases Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Sensation Disorders Niacin Nicotinic Acids Tocopherols Vitamin E Tocotrienols alpha-Tocopherol Diphenidol Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on June 22, 2017