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临床试验/NCT05623384
NCT05623384招募中不适用

Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness

Zhuan Zhang1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年11月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Mean Hearing Threshold (PTA)

研究概览

简要总结

Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery
  • Age 18 to 80 years
  • ASA classification Ⅰ~Ⅲ grade

排除标准

  • Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease
  • People with coagulation disorders or on anticoagulation therapy
  • Infection at the puncture site
  • Severe systemic diseases that cannot cooperate with treatment

研究组 & 干预措施

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Experimental

干预措施: Stellate ganglion block (Procedure)

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Experimental

干预措施: Facial and glossopharyngeal nerve blocks (Procedure)

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Experimental

干预措施: Mecobalamin Tablets (Drug)

Stellate ganglion block group

Experimental

干预措施: Stellate ganglion block (Procedure)

Stellate ganglion block group

Experimental

干预措施: Mecobalamin Tablets (Drug)

Control group

Other

干预措施: Mecobalamin Tablets (Drug)

结局指标

主要结局

Mean Hearing Threshold (PTA)

时间窗: Baseline (Before treatment),1 month and 2 months after treatment

The average of hearing thresholds at six frequencies (250, 500, 1000, 2000, 4000, and 8000 Hz) was recorded as the mean hearing threshold (PTA).

次要结局

未报告次要终点

研究者

发起方
Zhuan Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhuan Zhang

Clinical Professor

Yangzhou University

研究点 (1)

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