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Completed

NCT Number: NCT01574313

Effect of Stellate Ganglion Block on Meniere's Disease

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).

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Key information

Conditions

Vertigo Ear Diseases Endolymphatic Hydrops Hearing Disorders Hearing Loss Labyrinth Diseases Meniere Disease Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vestibular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

i Mei Medical Center Tainan, Taiwan, Taiwan

Tainan, 70014, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stellate ganglion block

Procedure

stellate ganglion block

0.25mg, fludiazine

Drug

0.25mg of erispan@ (fludiazine), p.o. one dose only.

Other names: 0.25mg of erispan@

25mg cephadol@ (diphenidol)

Drug

25mg cephadol@ (diphenidol) p.o. one dose only.

200mg kentons@ (tocopherol nicotinate).

Drug

200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chi Mei Medical Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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