- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05932485
Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting
December 18, 2025 updated by: Zhuan Zhang, Yangzhou University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China
- the Affiliated Hospital of Yangzhou University, Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Left stellate ganglion block
Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml
|
Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.
|
|
No Intervention: Control
do nothing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 5 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
|
|
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)
|
T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).
|
|
AF burden
Time Frame: within 5 days after surgery
|
The percentage of the time during which atrial fibrillation occurs in the overall recorded time.
|
within 5 days after surgery
|
|
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.
|
within 5 days after surgery
|
|
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.
|
within 5 days after the operation
|
|
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.
|
end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively
|
|
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.
|
end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively
|
|
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.
|
end of surgery, 24hour postoperatively, 72hour postoperatively
|
|
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
|
end of surgery, 24hour postoperatively, 72hour postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
June 1, 2024
Study Completion (Actual)
June 1, 2024
Study Registration Dates
First Submitted
June 10, 2023
First Submitted That Met QC Criteria
July 1, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
December 22, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230609
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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