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Completed

NCT Number: NCT05932485

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

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.

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Key information

Conditions

Stellate Ganglion Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The occurrence of new atrial fibrillation was detected by ECG monitoring

    Time frame: 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 outcomes

  1. AF burden

    Time frame: within 5 days after surgery

    The percentage of the time during which atrial fibrillation occurs in the overall recorded time.

  2. Duration of the first episode of POAF

    Time frame: within 5 days after surgery

    The duration from the onset to the resolution of the first atrial fibrillation after surgery.

  3. Need for Antiarrhythmic treatments

    Time frame: within 5 days after the operation

    Record the types of medications used and whether electrical cardioversion has been used.

  4. the concentration of interleukin-6

    Time frame: 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.

  5. the concentration of CRP

    Time frame: 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.

  6. Changes of intraoperative Left ventricular diastolic function

    Time frame: T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).

    Left ventricular diastolic function were measured by transesophageal echocardiography (TEE)

  7. the concentration of Hs-cTnT

    Time frame: end of surgery, 24hour postoperatively, 72hour postoperatively

    hs-cTnT is an important biomarker used for detecting cardiac injury.

  8. the concentration of CK-MB

    Time frame: 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

  9. postoperative adverse reactions

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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