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Clinical trial

The Effect of Preoperative Stellate Ganglion Block on Postoperative Atrial Fibrillation After Video-assisted Thoracoscopic Surgeries: A Randomized Controlled Trial

ID
Name
SGB and POAF
Description
The aim of this study is to test if stellate ganglion block can decrease the incidence of atrial fibrillation after video-assisted thoracoscopic surgery and the way it works.
Trial arms
Trial start
2023-03-27
Estimated PCD
2023-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
stellate ganglion blocks
At the level between C6 and C7, a 25-gauge needle is inserted laterally, and the needle tip is placed posterior to the carotid artery and anterior to the longus colli muscle using an in-plane approach.
Arms:
SGB group, control group
Ropivacaine
5 mL of 0.5% ropivacaine injected in the plane of the right stellate ganglion
Arms:
SGB group
Other names:
SGB group
Sham treatment
5 mL of saline injected in the plane of the right stellate ganglion
Arms:
control group
Other names:
Control group
Size
480
Primary endpoint
Primary outcome is the incidence of POAF using dynamic electrocardiogram.
within 48 hours post-surgery
Eligibility criteria
Inclusion Criteria: * 1.patients undergoing elective thoracoscopic lobectomy; * 2.patients with one or more risk factors of POAF. According to literature, risks factors of POAF including male, aged over 65, obesity (BMI\>30kg/m2), cardiac co-morbidity ( hypertension, myocardial infarction, heart failure, arrhythmia, history of valve procedure), diabetes, chronic renal insufficiency (increased creatinine level), obstructive sleep apnea syndrome (diagnosed or STOP-BANG scores ≥3). Exclusion Criteria: * 1. patients with permanent atrial fibrillation, left ventricular or right ventricular pacemaker implantation or removal; * 2. patients use antiarrhythmic drugs (except beta-blockers); * 3.patients use immunosuppressive drugs preoperatively; * 4.patients with active infection or sepsis; * 5. patients with neurologic disorder; * 6.patients with immune deficiency syndrome.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 480, 'type': 'ESTIMATED'}}
Updated at
2023-04-06

1 organization

2 products

1 indication

Organization
Peking University People's Hospital
Product
Ropivacaine
Indication
Atrial Fibrillation
Product
Sham treatment