Clinical trial NCT06225076: Efficacy of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
Official title: A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bulbar Palsy
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 20
measure: Video Fluoroscopic Swallowing Study
timeFrame: day 1 and day 20
measure: Murray secretion severity scale
timeFrame: day 1 and day 20
measure: Yale pharyngeal residue severity rating scale
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da First Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: