Effect of Stellate Ganglion Block on Meniere's Disease

Vertigo Clinical Trial

Official title:

Effect of Stellate Ganglion Block on Meniere's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574313
• Other study ID #: SGB09804-003
• Secondary ID: CMH09804-003
• Status: Completed
• Phase: Phase 4
• First received: April 1, 2012
• Last updated: April 10, 2012
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Chi Mei Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniere Disease
• Vertigo

Intervention

Procedure:
• stellate ganglion block
stellate ganglion block

Drug:
• 0.25mg, fludiazine
0.25mg of erispan@ (fludiazine), p.o. one dose only.
• 25mg cephadol@ (diphenidol)
25mg cephadol@ (diphenidol) p.o. one dose only.
• 200mg kentons@ (tocopherol nicotinate).
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Locations

Country	Name	City	State
Taiwan	i Mei Medical Center Tainan, Taiwan, Taiwan	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chi Mei Medical Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ECoG was reorded 2 hours after SGB	No
Secondary	SP/AP recorded at 4 hours after SGB	SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB	4 hours after SGB	No
Secondary	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	6 hours after SGB	No
Secondary	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	6 hours after SGB	No