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Deep Sedation in Catheter Ablation of Atrial Fibrillation
Sponsor: The First Affiliated Hospital of Dalian Medical University
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.
Official title: Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1334
Start Date
2025-03-03
Completion Date
2027-12-31
Last Updated
2025-03-04
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (16)
Anhui Provincial Hospital
Hefei, Anhui, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NanFang Hospital
Guangzhou, Guangdong, China
Jiangsu Provincial Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
The Affiliated Hospital Of Medical School Of Ningbo University
Ningbo, Zhejiang, China