NCT06836999

Deep Sedation in Catheter Ablation of Atrial Fibrillation

Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,334 (estimated)
• Sponsor: The First Affiliated Hospital of Dalian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation, Paroxysmal or Persistent
• Deep Sedations
• Conscious Sedation

Interventions

Type	Name	Description
PROCEDURE	deep sedation	The deep sedation was inducted using atropine 0.5 mg iv administered 15 min before the procedure to avoid aspiration. In the EP lab, anesthesia preparation is performed, including invasive arterial blood pressure monitoring via puncture of the radial artery or brachial artery. Noninvasive BP monitoring every 5 minutes is also permitted. Subsequently, midazolam 1-2mg or accompanied with propofol 0.3-0.5 mg/kg is administered intravenously at the start of the CA procedure (i.e., femoral vein puncture), and fentanyl 25 µg is administered intravenously. Then, continuous titrated infusion of propofol 0.2-0.5mg/kg/h for anesthesia maintenance throughout the CA procedure. An additional iv fentanyl (25-50 µg) is administrated at the beginning of RF applications. Further boluses or additional drugs are administrated as needed to maintain analgesia during the procedure. The anesthesiologist is responsible for administering anesthesia and administering medication.
PROCEDURE	Conscious sedation	This protocol is aimed at analgesia, with local infiltration of lidocaine for femoral vein puncture followed by intravenous administration of fentanyl (1-2 ug/kg/h). The operator determines the dose of fentanyl and midazolam. A midazolam 1-5 mg bolus is administrated before electrical cardioversion is performed or when the patient is nervous.

Timeline

• Start date: 2025-03-03
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2025-02-20
• Last updated: 2025-03-04

Locations

16 sites across 1 country: China