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

NCT05932485 | Completed DMC

• 1 other identifier: 20230609
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Stellate Ganglion Block

Outcome Measures

Primary Outcomes (1)

• The occurrence of new atrial fibrillation was detected by ECG monitoring

  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.

  Within 5 days after surgery

Secondary Outcomes (9)

• AF burden

  within 5 days after surgery

• Duration of the first episode of POAF

  within 5 days after surgery

• Need for Antiarrhythmic treatments

  within 5 days after the operation

• the concentration of interleukin-6

  end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively

• the concentration of CRP

  end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively

Study Arms (2)

Left stellate ganglion block

EXPERIMENTAL

Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml

Procedure: Stellate nerve block

Control

NO INTERVENTION

do nothing

Interventions

Stellate nerve block PROCEDURE

Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.

Left stellate ganglion block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yangzhou University: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: July 6, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CN (1)