Text Size

Effect of Stellate Ganglion Block on Meniere's Disease

This study has been completed.
Sponsor:
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
History of Changes
  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:

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
Other Name: 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.
Other Name: 25mg cephadol@ (diphenidol)
Drug: 200mg kentons@ (tocopherol nicotinate).
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
Other Name: 200mg kentons@ (tocopherol nicotinate).

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
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
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

No publications provided

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:
Synovial Cyst
Ganglion Cysts
Meniere Disease
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
Diphenidol
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on October 17, 2012