Effect of Stellate Ganglion Block on Meniere's Disease

Phase 4

Completed

• Conditions: Vertigo; Meniere Disease
• Interventions: Procedure: stellate ganglion block; Drug: 0.25mg, fludiazine; Drug: 25mg cephadol@ (diphenidol); Drug: 200mg kentons@ (tocopherol nicotinate).

• Registration Number: NCT01574313
• Lead Sponsor: Chi Mei Medical Hospital

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).

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2011-04
• Study Completion: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-01
• Study First Submitted QC: 2012-04-08
• Study First Posted: 2012-04-10
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate ganglion block	stellate ganglion block	treated with SGB
Oral medication	0.25mg, fludiazine	treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
Oral medication	25mg cephadol@ (diphenidol)	treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
Oral medication	200mg kentons@ (tocopherol nicotinate).	treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Primary Outcome Measures

Name	Time	Method
SP/AP of Electrocochleography	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 Outcome Measures

Name	Time	Method
SP/AP recorded at 4 hours after SGB	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	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	6 hours after SGB	scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB

Trial Locations

Locations (1)

i Mei Medical Center Tainan, Taiwan, Taiwan; 🇨🇳 Tainan, Taiwan