Effect of Stellate Ganglion Block on Meniere’s Disease

Overview

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).

Full Title of Study: “Effect of Stellate Ganglion Block on Meniere’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 2011

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).

Interventions

  • Procedure: stellate ganglion block
    • stellate ganglion block
  • Drug: 0.25mg, fludiazine
    • 0.25mg of erispan@ (fludiazine), p.o. one dose only.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Stellate ganglion block
    • treated with SGB
  • Active Comparator: Oral medication
    • treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chi Mei Medical Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yung-Song Lin, Chairman of department of Otolaryngology – Chi Mei Medical Hospital
  • Overall Official(s)
    • Yung-Song Lin, M.D., Principal Investigator, Chi Mei Medical Hospital

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