Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation

1. Research Title: A Study on the Safety and Efficacy of Deep Sedation WithDexmedetomidine Combined With Remimazolam and Remifentanil Versus GeneralAnaesthesia for Radiofrequency Ablation of Atrial Fibrillation 2. Research Objective: The aim of this study is to compare the safety and efficacy ofdeep sedation using a combination of dexmedetomidine and remimazolam versusremifentanil, and general anaesthesia, in patients undergoing pulsed electric fieldablation for atrial fibrillation. Through this study, we hope to optimise themanagement of the perioperative period for atrial fibrillation pulse field ablationand develop a carefully designed deep sedation protocol based on modernpharmacology. This protocol will maximise patient comfort, facilitate the surgeon'sprocedure, and enhance the efficiency of overall healthcare resource utilisation,whilst ensuring surgical success and patient safety. Consequently, it will providecrucial anaesthetic support for the standardisation and widespread adoption ofatrial fibrillation pulse field ablation technology. 3. Study Design: Interventional clinical study 4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation atthe Second Affiliated Hospital of Nanchang University between January 2026 andJanuary 2027. 5. Sample Size: N=80 patients, randomly assigned using a computer‐generated randomnumber table to the deep sedation group (n=40) or general anesthesia group (n=40) ata 1:1 ratio. 6. Inclusion and Exclusion Criteria:Inclusion Criteria: ① Age 18‐75 years (inclusive); ② Clinically diagnosed withatrial fibrillation, indicated for pulse field ablation, and scheduled for catheterablation; ③ Voluntarily agrees to participate in the trial and has signed informedconsent; ④ Willing to comply with the trial requirements and complete the requiredfollow‐up.Exclusion Criteria: ① Left atrial diameter > 55 mm; ② Transesophagealechocardiography indicates a thrombus in the left atrium; ③ Contraindications toanticoagulation 7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrialfibrillation, CHA2DS2‐VASc score, hemoglobin, left atrial diameter, ejectionfraction, and the prevalence of diabetes, hypertension, congestive heart failure,stroke/TIA, coronary heart disease and renal impairment.(2) Surgical Data: Durationof interventional procedures, X‐ray exposure, operating theatre occupancy time,success rate of acute PVI, calibration deviation rate, incidence of hypoxemia andhypotension, Numerical Rating Scale (NRS) scores for pain, and postoperativecomplications. 8. Statistical Analysis: Data analysis was performed using IBM SPSS Statistics 26.0software; continuous variables following a normal distribution are expressed as mean± standard deviation, and comparisons between two independent samples were performedusing t‐tests; categorical variables are presented as frequencies and percentages,and comparisons were performed using chi‐square tests; a two‐sided P‐value of <0.05was considered statistically significant.