The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:
1. Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia? 2. What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.
Participants will:
1. Receive the assigned anesthetic strategy combined with standardized PFA procedure 2. Complete intraoperative vital sign and related index monitoring 3. Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording
Aged 18 to 80 years
Diagnosed with paroxysmal atrial fibrillation
No prior history of catheter ablation for atrial fibrillation/atrial flutter
Scheduled to undergo pulsed-field ablation
Obstructive sleep apnea-hypopnea syndrome (OSAHS)
Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
Body mass index (BMI) >30 kg/m² or <20 kg/m²
Preoperative pulse oxygen saturation (SpO₂) <93%
Parallel
conscious sedation
Procedure/SurgeryMedications: Remimazolam toluenesulfonate injection (25 mg) + Fentanyl citrate injection (0.1 mg) + Lidocaine (100 mg). Administration method: Remimazolam: 2 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 1 mg/mL. The target Bispectral Index (BIS) is 60-80, and the infusion rate of remimazolam is adjusted according to the BIS and patient responses. Fentanyl citrate: 5 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 0.01 mg/mL. Dose reduction and slower injection rate are required for patients with hepatic/renal insufficiency, obesity, or elderly/weak conditions.
General Anesthesia (control group)
Procedure/SurgeryAfter femoral vein puncture, anesthesia induction was performed with remimazolam (0.2-0.3 mg/kg), sufentanil (0.3-0.4 μg/kg) and rocuronium (0.6 mg/kg) following standard monitoring and preoxygenation. A laryngeal mask airway was inserted upon loss of consciousness and adequate muscle relaxation, with lung-protective mechanical ventilation applied at tidal volume 6-8 mL/kg, respiratory rate 10-14 breaths/min, I:E 1:2, FiO₂ 60% and fresh gas flow 2-3 L/min to maintain PaCO₂ at 35-45 cmH₂O. Anesthesia was maintained with continuous intravenous ciprofol (0.4-1 mg/kg/h) and remifentanil (0.1-0.2 μg/kg/min) to keep BIS 60-80 and MAP \>70 mmHg, with vasoactive agents as needed. Anesthetics were discontinued before surgery end; the laryngeal mask airway was removed after the patient regained consciousness with satisfactory spontaneous breathing, and antagonistic drugs were used if necessary.
Primary outcome
persistent systolic blood pressure \<85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ \<85%) for more than 60 seconds.
Individual components of the primary composite endpoint
persistent systolic blood pressure \<85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ \<85%) for more than 60 seconds.
The number of occurrences of each component of the primary outcome
The number of occurrences of each component of the primary outcome: (1) Systolic blood pressure persistently below 85 mmHg for more than 60 sec; or (2) Persistent hypoxemia (SpO₂ \< 85%) for more than 60 seconds.
Sedation difficulty score
1-10; 1 = easiest, 10 = most difficult
Total procedure time
from femoral vein puncture to sheath removal
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