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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
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.
Study Design: Interventional clinical study
Study Subjects: Patients with atrial fibrillation scheduled for catheter ablation at the Second Affiliated Hospital of Nanchang University between January 2026 and January 2027.
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.
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
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Sedation Group | Experimental | Patients undergoing atrial fibrillation pulsed field ablation under a novel deep sedation protocol |
|
| General Anesthesia Group | Placebo Comparator | Patients undergoing atrial fibrillation pulsed field ablation under general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Deep Sedation Protocol | Procedure | A deep sedation protocol using dexmedetomidine, remifentanil and remazolam for atrial fibrillation pulse field ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room Occupancy Time | 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. | From Operating Room entry to Operating Room exit |
| Net Procedure Duration | Defined as the time from the first skin puncture for vascular access to the removal of the last catheter. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Recovery Time | The time interval from the end of the procedure until the patient meets the criteria for transfer back to the general ward | From procedure completion to transfer to the general ward, assessed up to 24 hours post-procedure |
| Acute Pulmonary Vein Isolation (PVI) Success Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39576055 | Result | Rillig A, Hirokami J, Moser F, Bordignon S, Rottner L, Shota T, My I, Urbani A, Lemoine M, Kheir J, Schenker N, Urbanek L, Govorov K, Schaack D, Obergassel J, Riess J, Ismaili D, Kirchhof P, Ouyang F, Schmidt B, Reissmann B, Chun KJ, Metzner A. General anaesthesia and deep sedation for monopolar pulsed field ablation using a lattice-tip catheter combined with a novel three-dimensional mapping system. Europace. 2024 Nov 1;26(11):euae270. doi: 10.1093/europace/euae270. | |
| 40287932 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Standard General Anesthesia | Procedure | Atrial fibrillation pulse filed ablation using a standard endotracheal intubation general anaesthesia protocol |
|
The percentage of pulmonary veins successfully isolated using pulsed field ablation (PFA) as confirmed by the electrophysiological mapping system. |
| At the end of the ablation procedure |
| Incidence of Hypoxemia | Percentage of patients experiencing oxygen saturation (SpO2) < 90% requiring intervention (e.g., increasing oxygen flow or airway maneuvers). | Periprocedural period |
| Incidence of Hypotension | 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). | Periprocedural period |
| Patient Pain Intensity (NRS Score) | Patient-reported pain levels assessed using the Numerical Rating Scale (0-10, where 0 is no pain and 10 is the worst pain imaginable). | 2 hours and 24 hours post-operation |
| Total Fluoroscopy Dose (DAP) | The cumulative radiation exposure to the patient, measured as Dose Area Product (DAP) in cGy·cm². | At the end of the procedure |
| Incidence of Perioperative Complications | 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. | up to 30 days post-procedure |
| Result |
| Sochorova V, Kunstatova V, Osmancik P, Duska F, Herman D, Waldauf P, Poviser L, Karch J, Znojilova L, Filipcova V, Hozmanova J, Vesela J, Hozman M. COOPERATIVE-PFA: A Three-Arm Randomized Controlled Trial. Circulation. 2025 Jul 22;152(3):150-159. doi: 10.1161/CIRCULATIONAHA.125.074427. Epub 2025 Apr 27. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |