Atrial Fibrillation (AF)
Conditions
Keywords
atrial fibrillation, pulse field ablation, deep sedation, general anesthesia, Catheter ablation
Brief summary
1. Research Title: A Study on the Safety and Efficacy of Deep Sedation With Dexmedetomidine Combined With Remimazolam and Remifentanil Versus General Anaesthesia for Radiofrequency Ablation of Atrial Fibrillation 2. Research Objective: The aim of this study is to compare the safety and efficacy of deep sedation using a combination of dexmedetomidine and remimazolam versus remifentanil, and general anaesthesia, in patients undergoing pulsed electric field ablation for atrial fibrillation. Through this study, we hope to optimise the management of the perioperative period for atrial fibrillation pulse field ablation and develop a carefully designed deep sedation protocol based on modern pharmacology. This protocol will maximise patient comfort, facilitate the surgeon's procedure, and enhance the efficiency of overall healthcare resource utilisation, whilst ensuring surgical success and patient safety. Consequently, it will provide crucial anaesthetic support for the standardisation and widespread adoption of atrial fibrillation pulse field ablation technology. 3. Study Design: Interventional clinical study 4. Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027. 5. Sample Size: N=80 patients, randomly assigned using a computer-generated random number table to the deep sedation group (n=40) or general anesthesia group (n=40) at a 1:1 ratio. 6. Inclusion and Exclusion Criteria: Inclusion Criteria: ① Age 18-75 years (inclusive); ② Clinically diagnosed with atrial fibrillation, indicated for pulse field ablation, and scheduled for catheter ablation; ③ Voluntarily agrees to participate in the trial and has signed informed consent; ④ Willing to comply with the trial requirements and complete the required follow-up. Exclusion Criteria: ① Left atrial diameter \> 55 mm; ② Transesophageal echocardiography indicates a thrombus in the left atrium; ③ Contraindications to anticoagulation 7. Observational Indicators:(1) Baseline Data: Age, sex, BMI, type of atrial fibrillation, CHA2DS2-VASc score, hemoglobin, left atrial diameter, ejection fraction, and the prevalence of diabetes, hypertension, congestive heart failure, stroke/TIA, coronary heart disease and renal impairment.(2) Surgical Data: Duration of interventional procedures, X-ray exposure, operating theatre occupancy time, success rate of acute PVI, calibration deviation rate, incidence of hypoxemia and hypotension, Numerical Rating Scale (NRS) scores for pain, and postoperative complications. 8. Statistical Analysis: Data analysis was performed using IBM SPSS Statistics 26.0 software; continuous variables following a normal distribution are expressed as mean ± standard deviation, and comparisons between two independent samples were performed using t-tests; categorical variables are presented as frequencies and percentages, and comparisons were performed using chi-square tests; a two-sided P-value of \<0.05 was considered statistically significant.
Interventions
PROCEDUREStandardized Deep Sedation Protocol
A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation
PROCEDUREStandard General Anesthesia
Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol
Sponsors
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 75 years, inclusive * Clinically diagnosed atrial fibrillation * Indicated for pulsed field ablation and scheduled for pulsed field ablation catheter procedure * Able and willing to provide written informed consent * Willing to comply with study procedures and follow-up requirements
Exclusion criteria
* Left atrial diameter \>55 mm * Presence of left atrial thrombus detected by transesophageal echocardiography * Contraindications to anticoagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating Room Occupancy Time | From Operating Room entry to Operating Room exit | The duration from the patient's entry into the operating room to their departure from the room. This includes anesthetic induction, the surgical procedure, and emergence/extubation. |
| Net Procedure Duration | During the procedure | Defined as the time from the first skin puncture for vascular access to the removal of the last catheter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Recovery Time | From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure | The time interval from the end of the procedure until the patient meets the criteria for transfer back to the general ward |
| Acute Pulmonary Vein Isolation (PVI) Success Rate | At the end of the ablation procedure | The percentage of pulmonary veins successfully isolated using pulsed field ablation (PFA) as confirmed by the electrophysiological mapping system. |
| Incidence of Hypoxemia | Periprocedural period | Percentage of patients experiencing oxygen saturation (SpO2) \< 90% requiring intervention (e.g., increasing oxygen flow or airway maneuvers). |
| Incidence of Hypotension | Periprocedural period | Percentage of patients experiencing at least one episode of hypotension during the procedure. Hypotension is defined as a Systolic Blood Pressure (SBP) \< 90 mmHg or a decrease of more than 20% from the baseline value, requiring clinical intervention (such as fluid bolus or administration of vasopressors like phenylephrine or ephedrine). |
| Patient Pain Intensity (NRS Score) | 2 hours and 24 hours post-operation | Patient-reported pain levels assessed using the Numerical Rating Scale (0-10, where 0 is no pain and 10 is the worst pain imaginable). |
| Total Fluoroscopy Dose (DAP) | At the end of the procedure | The cumulative radiation exposure to the patient, measured as Dose Area Product (DAP) in cGy·cm². |
| Incidence of Perioperative Complications | up to 30 days post-procedure | Occurrence of procedure-related adverse events, including cardiac tamponade, stroke/TIA, vascular access site complications (e.g., hematoma, pseudoaneurysm), phrenic nerve injury, and anesthesia-related complications. |
Countries
China
Outcome results
None listed