Effect of Stellate Ganglion Block on Meniere's Disease

Study Description

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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

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).

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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
2. 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
3. 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

Eligibility Criteria

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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.

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	April 10, 2012
Last Update Posted:	April 11, 2012
Last Verified:	April 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; 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