Effect of Stellate Ganglion Block on Meniere's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yung-Song Lin, Chi Mei Medical Hospital

ClinicalTrials.gov Identifier:

NCT01574313

First received: April 1, 2012

Last updated: April 10, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2012

Last Updated Date

April 10, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

SP/AP of Electrocochleography [ Time Frame: ECoG was reorded 2 hours after SGB ] [ Designated as safety issue: No ]

SP/AP of ECoG was recorded 2 hours after SGB. to be compared with the SP/AP of ECoG recorded before treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01574313 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

SP/AP recorded at 4 hours after SGB [ Time Frame: 4 hours after SGB ] [ Designated as safety issue: No ]
SP/AP recorded at 4 hours after SGB was compared with that of pretreatment with SGB
SP/AP recorded at 6 hours after SGB [ Time Frame: 6 hours after SGB ] [ Designated as safety issue: No ]
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 [ Time Frame: 6 hours after SGB ] [ Designated as safety issue: No ]
scores of verbal scale for vertigo recorded at 6 hours after SGB was compared to the scores recorded before SGB

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Stellate Ganglion Block on Meniere's Disease

Official Title ^ICMJE

Effect of Stellate Ganglion Block on Meniere's Disease

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Vertigo
Meniere Disease

Intervention ^ICMJE

Procedure: stellate ganglion block
stellate ganglion block

Other Name: stellate ganglion block
Drug: 0.25mg, fludiazine
0.25mg of erispan@ (fludiazine), p.o. one dose only.

Other Name: 0.25mg of erispan@
Drug: 25mg cephadol@ (diphenidol)
25mg cephadol@ (diphenidol) p.o. one dose only.

Other Name: 25mg cephadol@ (diphenidol)
Drug: 200mg kentons@ (tocopherol nicotinate).
200mg kentons@ (tocopherol nicotinate) p.o. one dose only.

Other Name: 200mg kentons@ (tocopherol nicotinate).

Study Arm (s)

Experimental: Stellate ganglion block
treated with SGB

Intervention: Procedure: stellate ganglion block
Active Comparator: Oral medication
treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).
Interventions:
- Drug: 0.25mg, fludiazine
- Drug: 25mg cephadol@ (diphenidol)
- Drug: 200mg kentons@ (tocopherol nicotinate).

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

30 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01574313

Other Study ID Numbers ^ICMJE

SGB09804-003, CMH09804-003

Has Data Monitoring Committee

Yes

Responsible Party

Yung-Song Lin, Chi Mei Medical Hospital

Study Sponsor ^ICMJE

Chi Mei Medical Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Yung-Song Lin, M.D.

Chi Mei Medical Hospital

Information Provided By

Chi Mei Medical Hospital

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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