Effect of Stellate Ganglion Block on Meniere's Disease - Full Text View

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 Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: Ménière disease nonsyndromic hearing loss

MedlinePlus related topics: Dizziness and Vertigo Meniere's Disease Vitamin E

Drug Information available for: alpha-Tocopherol Niacin Tocopherol alpha-Tocopherol succinate Tocopherol acetate DL-alpha-Tocopherol

U.S. FDA Resources

Further study details as provided by Chi Mei Medical Hospital:

Primary Outcome Measures:

SP/AP of Electrocochleography [ Time Frame: ECoG was reorded 2 hours after SGB ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received:	April 1, 2012
Last Updated:	April 10, 2012
Health Authority:	Taiwan: Department of Health

Keywords provided by 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 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

ClinicalTrials.gov processed this record on September 29, 2016