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Clinical trial

Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study

ID
Name
SGB-Liuxian
Description
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. 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, Functional Oral Intake Scale, Drooling amount, depression are assessed.
Trial arms
Trial start
2024-04-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
Comprehensive rehabilitation
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training.
Arms:
Comparator: Comprehensive rehabilitation+placebo, Comprehensive rehabilitation+Stellate ganglion block
Stellate ganglion block
Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Comprehensive rehabilitation+Stellate ganglion block
Lidocaine hydrochloride
Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Comprehensive rehabilitation+Stellate ganglion block
Placebo injection
1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Arms:
Comparator: Comprehensive rehabilitation+placebo
Size
100
Primary endpoint
Drooling amount
day 1 and day 10
Eligibility criteria
Inclusion Criteria: * Age \>18 years. * Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006. * Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study. * Stable vital signs, conscious, able to cooperate with assessment and treatment. Exclusion Criteria: * Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases. * History of mental diseases or use of antipsychotics. * Complicated with cognitive impairment or consciousness dysfunction. * Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-17

1 organization

1 product

1 indication

Organization
Babujinaya Cela
Product
Lidocaine
Indication
Parkinson's disease