MedTrace Logo

Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

NCT07541339 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2026-04-21

No results posted yet for this study

Summary

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

Conditions

  • Atrial Fibrillation (Paroxysmal)

Interventions

PROCEDURE

conscious sedation

Medications: 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.

PROCEDURE

General Anesthesia (control group)

After 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.

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Ning Zhou · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2026-12-01
Completion
2027-03-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541339 on ClinicalTrials.gov