A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- Modified Barium Swallow Impairment Profile
研究概览
简要总结
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, ultrasound diagnostic devices, and penetration-aspiration scale, Flexible laryngoscope are used to assess swallowing function.
详细描述
Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- •Age >18 years.
- •First-time stroke.
- •Steady vital signs,
- •Transferred or admitted to the Department of Rehabilitation Medicine within 15-30d after onset.
- •No cognitive impairment or aphasia, with the Montreal Cognitive Assessment score ≥21 points.
- •No history of severe mental illness or psychotropic drug dependence.
- •Unsafe or insufficient oral intake, indicating the need for enteral feeding
排除标准
- •Contraindications for Stellate Ganglion Block..
- •Structural abnormalities of the oropharynx.
- •Complicated with other neurological diseases.
- •Tracheostomy tube inserted.
- •Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
- •Dysphagia caused by other possible diseases.
- •Pregnant females.
研究组 & 干预措施
Comprehensive rehabilitation+placebo
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: placebo injection (Behavioral)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Stellate ganglion block (Procedure)
Comprehensive rehabilitation+placebo
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Lidocaine Hydrochloride (Drug)
结局指标
主要结局
Modified Barium Swallow Impairment Profile
时间窗: day 1 before any intervention, day 11, and day 60
The Modified Barium Swallow Impairment Profile is used to evaluate the clinical severity of dysphagia. It consisted of 17 items. The total scores could range between 0 and 55, with higher scores indicating worse function.
次要结局
- Murray secretion severity scale(day 1 before any intervention, day 11, and day 60)
- Yale pharyngeal residue severity rating scale(day 1 before any intervention, day 11, and day 60)
- Penetration-Aspiration Scale(day 1 before any intervention, day 11, and day 60)
- Generalized Anxiety Disorder 7-item scale(day 1 before any intervention, day 11, and day 60)
- Movement distances of the hyoid bone(day 1 before any intervention, day 11, and day 60)
- Vertebral artery cerebral blood flow velocity(day 1 before any intervention, day 11, and day 60)
- Vertebral artery internal diameter(day 1 before any intervention, day 11, and day 60)
研究者
Zeng Xi
Research Director
Chao Phya Abhaibhubejhr Hospital