Effect of Stellate Ganglion Block on Meniere's Disease
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| ClinicalTrials.gov Identifier: NCT01574313 |
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Recruitment Status :
Completed
First Posted : April 10, 2012
Last Update Posted : April 11, 2012
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Sponsor:
Chi Mei Medical Hospital
Information provided by (Responsible Party):
Yung-Song Lin, Chi Mei Medical Hospital
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vertigo Meniere Disease | Procedure: stellate ganglion block Drug: 0.25mg, fludiazine Drug: 25mg cephadol@ (diphenidol) Drug: 200mg kentons@ (tocopherol nicotinate). | Phase 4 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Stellate Ganglion Block on Meniere's Disease |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | April 2011 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ménière disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Stellate ganglion block
treated with SGB
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Procedure: stellate ganglion block
stellate ganglion block |
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Active Comparator: Oral medication
treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
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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. |
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
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| Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| 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 ) |
| First Posted: | April 10, 2012 Key Record Dates |
| Last Update Posted: | April 11, 2012 |
| Last Verified: | April 2012 |
Keywords provided by Yung-Song Lin, Chi Mei Medical Hospital:
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stellate ganglion block. Meniere's disease. electrocochleography. vertigo. hearing impairment. |
Additional relevant MeSH terms:
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Meniere Disease Ganglion Cysts Vertigo Dizziness Cysts Neoplasms Mucinoses Connective Tissue Diseases Vestibular Diseases Labyrinth Diseases Ear Diseases Otorhinolaryngologic Diseases Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Sensation Disorders Endolymphatic Hydrops Tocopherols Vitamin E Tocotrienols alpha-Tocopherol Niacin Nicotinic Acids Diphenidol Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients |