Optic

ID

Name

2024-KY-0118

Description

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.

Trial arms

Trial start

2024-01-20

Estimated PCD

2024-05-25

Trial end

2024-06-01

Status

Completed

Treatment

Rehabilitation therapy

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. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding was provided.

Arms:

The comparison group, The observation group

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:

The observation group

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:

The observation group

Other names:

Lidocaine

Size

84

Primary endpoint

Penetration-Aspiration Scale

day 1 and day 14

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ACTUAL'}}

Updated at

2024-06-04

Organization

Zeng Changhao

Product

Lidocaine

Indication

Cerebral Small Vessel Diseases

A Randomized Controlled Trial For Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease