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临床试验/NCT01574313
NCT01574313已完成4 期

Effect of Stellate Ganglion Block on Meniere's Disease

Chi Mei Medical Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
SP/AP of Electrocochleography

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with unilateral Meniere's disease, according to the criteria of the American Academy of Otolaryngology-Head and Neck Surgery, AAO-HNS (1995)

排除标准

  • patients with coagulopathy,
  • arrhythmia,
  • myocardial ischemia,
  • glaucoma,
  • pregnant,
  • chronic otitis media or externa, and
  • past history of middle or inner ear surgery were excluded.

研究组 & 干预措施

Stellate ganglion block

Experimental

treated with SGB

干预措施: stellate ganglion block (Procedure)

Oral medication

Active Comparator

treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

干预措施: 0.25mg, fludiazine (Drug)

Oral medication

Active Comparator

treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

干预措施: 25mg cephadol@ (diphenidol) (Drug)

Oral medication

Active Comparator

treated with oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

干预措施: 200mg kentons@ (tocopherol nicotinate). (Drug)

结局指标

主要结局

SP/AP of Electrocochleography

时间窗: 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

次要结局

  • SP/AP recorded at 4 hours after SGB(4 hours after SGB)
  • SP/AP recorded at 6 hours after SGB(6 hours after SGB)
  • scores of verbal scale for vertigo recorded at 6 hours after SGB(6 hours after SGB)

研究者

发起方
Chi Mei Medical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yung-Song Lin

Chairman of department of Otolaryngology

Chi Mei Medical Hospital

研究点 (1)

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