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

Primary Purpose

Stellate Ganglion Block

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate nerve block
Sponsored by
Yangzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stellate Ganglion Block

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the Affiliated Hospital of Yangzhou University, Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Left stellate ganglion block

Control

Arm Description

Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml

do nothing

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
June 10, 2023
Last Updated
July 1, 2023
Sponsor
Yangzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT05932485
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yangzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stellate Ganglion Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left stellate ganglion block
Arm Type
Experimental
Arm Description
Left stellate ganglion block under ultrasound guidance was administered with 0.375% Ropivacaine hydrochloride 5 ml
Arm Title
Control
Arm Type
No Intervention
Arm Description
do nothing
Intervention Type
Procedure
Intervention Name(s)
Stellate nerve block
Intervention Description
Before the operation, the left stellate ganglion block was performed, and 0.375% ropivacaine 5ml was injected into the stellate ganglion.
Primary Outcome Measure Information:
Title
The occurrence of new atrial fibrillation was detected by ECG monitoring
Description
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.
Time Frame
Within 5 days after surgery
Secondary Outcome Measure Information:
Title
Changes in the inflammatory factor interleukin-6
Description
Detection of inflammatory factors by serum,It reflects the degree of inflammation in the body at different time points
Time Frame
Preoperatively, End of operation ,The first day after surgery, The Third day after surgery
Title
Changes in the Stress index cortisol
Description
Detection of Stress index by serum,It reflects the degree of stress in the body at different time points
Time Frame
Preoperatively, End of operation ,The first day after surgery, The Third day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan zhang, professor
Phone
+8615062791355
Email
zhangzhuancg@163.com
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University, Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Zhang, professor
Phone
+8615062791355
Ext
+8615062791355
Email
zhangzhuancg@163.com

12. IPD Sharing Statement

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

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