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The prevention effect of Sotalol for post-operative atrial fibrillation after coronary artery bypass grafting: a randomized contrlled trial

Phase 1
Recruiting
Conditions
coronary artery disease
Registration Number
ChiCTR2400088934
Lead Sponsor
Fuwai Hospital, Chinese Academy of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  1. Adult patients who are willing to participate in this study and can sign the informed consent form (=18 years old on the day of surgery).<br>2. Patients scheduled for elective isolated coronary artery bypass grafting surgery (without valve surgery).<br>3. Patients with sinus rhythm and no history of atrial fibrillation (including permanent atrial fibrillation, persistent atrial fibrillation, paroxysmal atrial fibrillation, and initial atrial fibrillation), and who do not need to use antiarrhythmic drugs (except beta-blockers) during surgery.
Exclusion Criteria
  1. Sinus bradycardia (heart rate <50 beats/min in awake state).<br>2. Sick sinus syndrome, second-degree and third-degree atrioventricular block, patients with pacemakers.<br>3. Baseline QTc interval >450 milliseconds, congenital or acquired long QT syndrome and history of torsade de pointes.<br>4. Incorrigible hypokalemia (<3.5 mmol/L), hypomagnesemia <0.75 mmol/L.<br>5. Acute myocardial infarction (occurring within two months), clinically uncontrolled heart failure (EF <40%), infective endocarditis, active pericarditis or myocarditis.<br>6. Bronchial asthma, severe obstructive pulmonary disease or other contraindications to beta-blocker therapy.<br>7. Creatinine clearance rate <40 ml/min.<br>8. Use of antiarrhythmic drug therapy (except beta-adrenergic receptor blockers).<br>8. History of drug allergy and serious adverse reactions to sotalol and metoprolol.<br>9. In any blood pressure measurement during preoperative hospitalization, systolic blood pressure <100 mmHg, or preoperative need for intravenous pumping of positive vasoactive drugs (such as dopamine, norepinephrine, epinephrine, etc.).

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
postoperative atrial fibrillation;
Secondary Outcome Measures
NameTimeMethod
all-cause death;cardiovascular-related death;stroke;post-operative length of stay;post-operative length of ICU stay;in-hospital cost;
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