Effect of Stellate Ganglion Block on Meniere's Disease

April 10, 2012 updated by: Yung-Song Lin, Chi Mei Medical Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 70014
        • i Mei Medical Center Tainan, Taiwan, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ECoG was reorded 2 hours after SGB

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours after 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
6 hours after 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
6 hours after SGB

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chi Mei Medical Hospital

Investigators

  • Principal Investigator: Yung-Song Lin, M.D., Chi Mei Medical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

April 1, 2012

First Submitted That Met QC Criteria

April 8, 2012

First Posted (Estimate)

April 10, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGB09804-003
  • CMH09804-003 (Other Grant/Funding Number: Chi Mei Medical Center, Taiwan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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