Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting

Not Applicable

Completed

• Conditions: Stellate Ganglion Block
• Interventions: Procedure: Stellate nerve block

• Registration Number: NCT05932485
• Lead Sponsor: Yangzhou University

Brief Summary

Post-operative new-onset atrial fibrillation (POAF) is one of the most common arrhythmias in adults after direct intracardiac surgery with extracorporeal circulation. The incidence of POAF in coronary artery bypass grafting (CABG) is approximately 30%. POAF can lead to an increased risk of complications such as stroke, heart failure, and acute kidney injury, which not only prolongs the patient's hospital stay, but also increases hospital costs and mortality. operation, extracorporeal circulation, and the patient's underlying conditions (such as age, gender, hypertension, and diabetes), which cause sympathetic activation, inflammatory response, and myocardial ischemia in the organism. The stellate ganglion block (SGB) regulates the sympathetic tone of the innervated nerves and thus the autonomic function of the body. SGB can effectively regulate the sympathetic-parasympathetic imbalance. Also, SGB may exert some anti-inflammatory effects. In this study, ultrasound-guided SGB was used in CABG patients to investigate its effect on the occurrence of POAF.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-07-01
• Study First Posted: 2023-07-06
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patients undergoing first-time and elective coronary artery bypass grafting;
• ASA grade II-IV；
• The preoperative ECG showed sinus heart rate.

Exclusion Criteria

• The patient refused to participate in this study;
• Surgical procedures include any other type of heart surgery in addition to CABG；
• Allergic to known general anesthesia drugs;
• Patients with a history of neck surgery or abnormal neck anatomy;
• Patients with contraindications to SGB.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left stellate ganglion block	Stellate nerve block	Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml

Primary Outcome Measures

Name	Time	Method
The occurrence of new atrial fibrillation was detected by ECG monitoring	Within 5 days after surgery	ECG monitor shows atrial fibrillation. To be specific: 1)Irregular R-R interval (when atrioventricular conduction is present), 2) P wave disappearance, 3) irregular atrial activity.

Secondary Outcome Measures

Name	Time	Method
AF burden	within 5 days after surgery	The percentage of the time during which atrial fibrillation occurs in the overall recorded time.
Duration of the first episode of POAF	within 5 days after surgery	The duration from the onset to the resolution of the first atrial fibrillation after surgery.
Need for Antiarrhythmic treatments	within 5 days after the operation	Record the types of medications used and whether electrical cardioversion has been used.
the concentration of interleukin-6	end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively	Interleukin-6 (IL-6) is an important cytokine that plays a key role in immune responses, inflammation, and tumor development.
the concentration of CRP	end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively	C-reactive protein (CRP) is a protein produced by the liver that is mainly used to indicate the presence of inflammation in the body.
Changes of intraoperative Left ventricular diastolic function	T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).	Left ventricular diastolic function were measured by transesophageal echocardiography (TEE)
the concentration of Hs-cTnT	end of surgery, 24hour postoperatively, 72hour postoperatively	hs-cTnT is an important biomarker used for detecting cardiac injury.
the concentration of CK-MB	end of surgery, 24hour postoperatively, 72hour postoperatively	CK-MB is an enzyme primarily found in cardiac muscle cells. Its concentration is commonly used to assess cardiac damage, especially in the case of myocardial infarction
postoperative adverse reactions	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months	Record the occurrence of adverse reactions postoperative

Trial Locations

Locations (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University; 🇨🇳 Yangzhou, Jiangsu, China