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Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

NCT06176404 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2024-08-28

No results posted yet for this study

Summary

A prospective study was conducted on 84 CSVD patients with 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 SGB. 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.

Conditions

Interventions

DRUG

Stellate ganglion block

Based on the invention above, the patients in the observation group were provided with SGB, 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 SGB. 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.

BEHAVIORAL

Rehabilitation therapy

The study lasted 20d 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 (NGT) was provided.

Sponsors & Collaborators

  • Zeng Changhao

    lead OTHER

Principal Investigators

  • Nieto Luis, Master · Site Coordinator of United Medical Group located in Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-05-05
Completion
2023-05-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06176404 on ClinicalTrials.gov