Back to resultsEffect of Stellate Ganglion Block on Meniere's Disease
Primary Purpose
Vertigo, Meniere Disease
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
stellate ganglion block
0.25mg, fludiazine
25mg cephadol@ (diphenidol)
200mg kentons@ (tocopherol nicotinate).
Sponsored by
About this trial
This is an interventional treatment trial for Vertigo focused on measuring stellate ganglion block., Meniere's disease., electrocochleography., vertigo., hearing impairment.
Eligibility 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.
Sites / Locations
- i Mei Medical Center Tainan, Taiwan, Taiwan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stellate ganglion block
Oral medication
Arm Description
treated with SGB
treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
Outcomes
Primary Outcome Measures
SP/AP of Electrocochleography
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
SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB
SP/AP recorded at 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
scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01574313
Brief Title
Effect of Stellate Ganglion Block on Meniere's Disease
Official Title
Effect of Stellate Ganglion Block on Meniere's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chi Mei Medical Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Meniere Disease
Keywords
stellate ganglion block., Meniere's disease., electrocochleography., vertigo., hearing impairment.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stellate ganglion block
Arm Type
Experimental
Arm Description
treated with SGB
Arm Title
Oral medication
Arm Type
Active Comparator
Arm Description
treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
Intervention Type
Procedure
Intervention Name(s)
stellate ganglion block
Intervention Description
stellate ganglion block
Intervention Type
Drug
Intervention Name(s)
0.25mg, fludiazine
Other Intervention Name(s)
0.25mg of erispan@
Intervention Description
0.25mg of erispan@ (fludiazine), p.o. one dose only.
Intervention Type
Drug
Intervention Name(s)
25mg cephadol@ (diphenidol)
Intervention Description
25mg cephadol@ (diphenidol) p.o. one dose only.
Intervention Type
Drug
Intervention Name(s)
200mg kentons@ (tocopherol nicotinate).
Intervention Description
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
Primary Outcome Measure Information:
Title
SP/AP of Electrocochleography
Description
SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment
Time Frame
ECoG was reorded 2 hours after SGB
Secondary Outcome Measure Information:
Title
SP/AP recorded at 4 hours after SGB
Description
SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB
Time Frame
4 hours after SGB
Title
SP/AP recorded at 6 hours after SGB
Description
SP/AP recorded at 4 hours after SGB was compared with the SP/AP recorded before SGB
Time Frame
6 hours after SGB
Title
scores of verbal scale for vertigo recorded at 6 hours after SGB
Description
scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB
Time Frame
6 hours after SGB
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Song Lin, M.D.
Organizational Affiliation
Chi Mei Medical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
i Mei Medical Center Tainan, Taiwan, Taiwan
City
Tainan
ZIP/Postal Code
70014
Country
Taiwan
12. IPD Sharing Statement
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Effect of Stellate Ganglion Block on Meniere's Disease
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