Clinical trial NCT06228170: Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
Official title: A Randomized Controlled Study to Explore the Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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\&#39;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.

Primary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 20
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: day 1 and day 20
measure: Swallowing duration
timeFrame: day 1 and day 20
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 20
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Zheng Da yi Yuan Hospital
state: Henan
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References: