Stellate Ganglion BlockNCT05932485
Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting
A study testing Stellate nerve block in people with Stellate Ganglion Block, run by Yangzhou University at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- Stellate nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing first-time and elective coronary artery bypass grafting;
- ASA grade II-IV；
- The preoperative ECG showed sinus heart rate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
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
- Being tested
- Stellate nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate nerve blockProcedure or surgery
Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.
| Study group | Role | What they receive |
|---|---|---|
| Left stellate ganglion block | Experimental | Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml Receives: Procedure: Stellate nerve block |
| Control | No intervention | do nothing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 days after surgery
Secondary outcomes (9)
AF burden
The percentage of the time during which atrial fibrillation occurs in the overall recorded time.
Measured: within 5 days after surgery
Duration of the first episode of POAF
The duration from the onset to the resolution of the first atrial fibrillation after surgery.
Measured: within 5 days after surgery
Need for Antiarrhythmic treatments
Record the types of medications used and whether electrical cardioversion has been used.
Measured: within 5 days after the operation
the concentration of interleukin-6
Interleukin-6 (IL-6) is an important cytokine that plays a key role in immune responses, inflammation, and tumor development.
Measured: end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively
the concentration of CRP
C-reactive protein (CRP) is a protein produced by the liver that is mainly used to indicate the presence of inflammation in the body.
Measured: end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively
Changes of intraoperative Left ventricular diastolic function
Left ventricular diastolic function were measured by transesophageal echocardiography (TEE)
Measured: T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).
the concentration of Hs-cTnT
hs-cTnT is an important biomarker used for detecting cardiac injury.
Measured: end of surgery, 24hour postoperatively, 72hour postoperatively
the concentration of CK-MB
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
Measured: end of surgery, 24hour postoperatively, 72hour postoperatively
postoperative adverse reactions
Record the occurrence of adverse reactions postoperative
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932485
- Sponsor's protocol ID
- 20230609
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05932485
- Acronym / sponsor ID
- 20230609
- Conditions
- Stellate Ganglion Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left stellate ganglion block | Experimental | Procedure: Stellate nerve blockLeft stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml |
| Control | No intervention | –do nothing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing first-time and elective coronary artery bypass grafting;
- ASA grade II-IV；
- The preoperative ECG showed sinus heart rate.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate nerve blockBefore the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion. | Procedure or surgery | Left stellate ganglion block |
Primary outcome
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.
9 secondary outcomes
AF burden
Time frame: within 5 days after surgery
Duration of the first episode of POAF
Time frame: within 5 days after surgery
Need for Antiarrhythmic treatments
Time frame: within 5 days after the operation
the concentration of interleukin-6
Time frame: 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
Changes of intraoperative Left ventricular diastolic function
Time frame: T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).
the concentration of Hs-cTnT
Time frame: end of surgery, 24hour postoperatively, 72hour postoperatively
the concentration of CK-MB
Time frame: end of surgery, 24hour postoperatively, 72hour postoperatively
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate nerve block in people with Stellate Ganglion Block, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of new atrial fibrillation was detected by ECG monitoring (time frame: Within 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.