Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients (SGB-TBI)

Z

Zeng Changhao

Status

Withdrawn

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Rehabilitation therapy
Procedure: Stellate ganglion block

Study type

Interventional

Funder types

Other

Identifiers

NCT06228170
2024-KY-0119-002

Details and patient eligibility

About

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are: Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients. Traumatic Brain Injury Patients will be divided into the the control 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, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Full description

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are: Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients. Traumatic Brain Injury Patients will be divided into the the control 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, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
  • presence of no contraindication for Stellate Ganglion Block;
  • with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
  • informed consent form was obtained from the patient's family members, indicating their full understanding of the study and agreement to participate.

Exclusion criteria

  • unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
  • complicated with other intracranial lesions, such as stroke;
  • with severe consciousness disorders caused by other diseases.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

The observation group
Experimental group
Description:
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. 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)
Treatment:
Procedure: Stellate ganglion block
Behavioral: Rehabilitation therapy
The control group
Active Comparator group
Description:
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.
Treatment:
Behavioral: Rehabilitation therapy

Trial contacts and locations

1

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Central trial contact

Zhefeng Wang, Doctor; Weiji Zhao, Doctor

Data sourced from clinicaltrials.gov

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