A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Comprehensive rehabilitation
- Conditions
- Bulbar Palsy
- Sponsor
- Zeng Changhao
- Locations
- 1
- Primary Endpoint
- Penetration-Aspiration Scale
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
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 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.
Detailed Description
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 20-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- •Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- •Age \>18 years.
- •First-time stroke.
- •Steady vital signs,
- •Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.
Exclusion Criteria
- •The bulbar palsy caused by other diseases, such as neurodegenerative diseases.
- •Pseudobulbar palsy.
- •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.
Arms & Interventions
The observation group
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 20 days.
Intervention: Comprehensive rehabilitation
The observation group
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 20 days.
Intervention: Stellate ganglion block
The observation group
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 20 days.
Intervention: Lidocaine Hydrochloride
The control group
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 20 days.
Intervention: Comprehensive rehabilitation
Outcomes
Primary Outcomes
Penetration-Aspiration Scale
Time Frame: day 1 and day 20
On the day 1 and day 20, Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.
Secondary Outcomes
- Yale pharyngeal residue severity rating scale(day 1 and day 20)
- Functional Oral Intake Scale(day 1 and day 20)
- Video Fluoroscopic Swallowing Study(day 1 and day 20)
- Murray secretion severity scale(day 1 and day 20)