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Clinical Trials/NCT05932485
NCT05932485CompletedNot Applicable

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

Yangzhou University1 site in 1 country108 target enrollmentStarted: June 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
108
Locations
1
Primary Endpoint
The occurrence of new atrial fibrillation was detected by ECG monitoring

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • 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)
  • Changes of intraoperative Left ventricular diastolic function(T1 (after sternotomy and before CPB) and T2 (30 minute after CPB cessation).)
  • the concentration of CRP(end of surgery,24 hour postoperatively ,72 hour postoperatively ,5 day postoperatively)
  • the concentration of Hs-cTnT(end of surgery, 24hour postoperatively, 72hour postoperatively)
  • the concentration of CK-MB(end of surgery, 24hour postoperatively, 72hour postoperatively)
  • postoperative adverse reactions(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)

Investigators

Sponsor
Yangzhou University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zhuan Zhang

MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou University

Study Sites (1)

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