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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05932485
Other study ID # 20230609
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date June 1, 2024

Study information

Verified date July 2023
Source Yangzhou University
Contact Zhuan zhang, professor
Phone +8615062791355
Email zhangzhuancg@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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%. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Procedure:
Stellate nerve block
Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.

Locations

Country Name City State
China the Affiliated Hospital of Yangzhou University, Yangzhou University Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Within 5 days after surgery
Secondary Changes in the inflammatory factor interleukin-6 Detection of inflammatory factors by serum,It reflects the degree of inflammation in the body at different time points Preoperatively, End of operation ,The first day after surgery, The Third day after surgery
Secondary Changes in the Stress index cortisol Detection of Stress index by serum,It reflects the degree of stress in the body at different time points Preoperatively, End of operation ,The first day after surgery, The Third day after surgery
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