Clinical trial NCT05932485: Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting
Official title: Effect of Stellate Ganglion Block on New Atrial Fibrillation After Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stellate Ganglion Block
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The occurrence of new atrial fibrillation was detected by ECG monitoring
timeFrame: Within 5 days after surgery
Secondary outcomes:
measure: AF burden
timeFrame: within 5 days after surgery
measure: Duration of the first episode of POAF
timeFrame: within 5 days after surgery
measure: Need for Antiarrhythmic treatments
timeFrame: within 5 days after the operation
measure: the concentration of interleukin-6
timeFrame: end of surgery, 24 hour postoperatively, 72hour postoperatively, 5 day postoperatively
measure: the concentration of CRP
timeFrame: end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively
measure: Changes of intraoperative Left ventricular diastolic function
timeFrame: T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).
measure: the concentration of Hs-cTnT
timeFrame: end of surgery, 24hour postoperatively, 72hour postoperatively
measure: the concentration of CK-MB
timeFrame: end of surgery, 24hour postoperatively, 72hour postoperatively
measure: postoperative adverse reactions
timeFrame: 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
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References: