A Randomized Controlled Trial For Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Cerebral Small Vessel Diseases
- Sponsor
- Zeng Changhao
- Enrollment
- 84
- Locations
- 3
- Primary Endpoint
- Penetration-Aspiration Scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.
Detailed Description
This study is conducted for Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease. This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.
Investigators
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •Age\>18 years.
- •Meeting the diagnostic criteria for cerebral small vessel disease.
- •Dysphagia confirmed by Videofluoroscopic Swallowing Study
- •Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
- •No history of prior stroke.
- •Stable vital signs.
Exclusion Criteria
- •Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
- •Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease, Parkinson's disease, brain injury, etc.
- •Neurological blockade contraindications such as bleeding tendency, blocked site infection.
- •Unable to successfully finish the assessment of this study.
- •Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- •Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
- •Pregnant or nursing females
Arms & Interventions
The comparison group
The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.
Intervention: Rehabilitation therapy
The observation group
The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Based on the invention above, the patients in the observation group were provided, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).
Intervention: Rehabilitation therapy
The observation group
The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Based on the invention above, the patients in the observation group were provided, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).
Intervention: Stellate ganglion block
The observation group
The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Based on the invention above, the patients in the observation group were provided, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).
Intervention: Lidocaine Hydrochloride
Outcomes
Primary Outcomes
Penetration-Aspiration Scale
Time Frame: day 1 and day 14
On the day 1 and day 14, 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
- Modified Barium Swallow Impairment Profile(day 1 and day 14)
- Functional Oral Intake Scale(day 1 and day 14)
- Mini-Mental State Examination(day 1 and day 14)
- Modified Barthel Index(day 1 and day 14)