Optic

ID

Name

SGB-OSA

Description

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are: • Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Trial arms

Trial start

2024-02-29

Estimated PCD

2024-05-01

Trial end

2024-05-01

Status

Recruiting

Treatment

routine rehabilitation treatment

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy

Arms:

The control group, The experimental group

Stellate ganglion block

The patients were provided with Stellate ganglion block , using 0.5ml 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 experimental group

Lidocaine Hydrochloride Injection

The patients were provided with Stellate ganglion block , using 0.5ml 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 experimental group

Other names:

Lidocaine Hydrochloride

Size

80

Primary endpoint

Epworth Sleepiness Scale

day 1 and day 20

Eligibility criteria

Inclusion Criteria: * Patients aged over 18 years diagnosed with Obstructive Sleep Apnea by polysomnography * Patients with moderate to severe Obstructive Sleep Apnea * Patients who have undergone continuous positive airway pressure treatment for at least 3 months but have not achieved satisfactory therapeutic effects * Patients who voluntarily agree to receive stellate ganglion block treatment and sign the informed consent form Exclusion Criteria: * Patients with a history of allergy or contraindications to local anesthetics or corticosteroids * Patients with severe cardiovascular, cerebrovascular, respiratory, hepatic, or renal diseases * Patients with a history of neck surgery or cervical spine disease * Patients with psychiatric disorders or other medical conditions that may affect the safety or effectiveness of Stellate Ganglion Block treatment * Pregnant or lactating women * Patients who have participated in other clinical trials within the past 3 months

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-03-12

Organization

Zeng Changhao

Product

Lidocaine Hydrochloride

Indication

Obstructive Sleep Apnea

A Randomized Controlled Trial to Explore the Effect of Stellate Ganglion Block in Obstructive Sleep Apnea