Deep Sedation in Catheter Ablation of Atrial Fibrillation

NANot yet recruitingINTERVENTIONAL
Enrollment

1,334

Participants

Timeline

Start Date

March 3, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

December 31, 2027

Conditions
Atrial FibrillationAtrial Fibrillation, Paroxysmal or PersistentDeep SedationsConscious Sedation
Interventions
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.

Trial Locations (16)

116011

First Affiliated Hospital of Dalian Medical University, Dalian

200120

Shanghai East Hospital, Shanghai

210029

Jiangsu Provincial Hospital, Nanjing

215006

The First Affiliated Hospital of Soochow University, Suzhou

230036

Anhui Provincial Hospital, Hefei

266011

Qingdao Municipal Hospital, Qingdao

300010

Tianjin Chest Hospital, Tianjin

300050

Tianjin Medical University General Hospital, Tianjin

310009

The Second Affiliated Hospital of Zhejiang University, Hangzhou

310016

Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine, Hangzhou

315211

The Affiliated Hospital Of Medical School Of Ningbo University, Ningbo

330006

The First Affiliated Hospital of Nanchang University, Nanchang

330008

The Second Affiliated Hospital of Nanchang University, Nanchang

510080

Guangdong Provincial People's Hospital, Guangzhou

510515

NanFang Hospital, Guangzhou

030001

Shanxi Cardiovascular Hospital, Taiyuan

All Listed Sponsors
lead

The First Affiliated Hospital of Dalian Medical University

OTHER

NCT06836999 - Deep Sedation in Catheter Ablation of Atrial Fibrillation | Biotech Hunter | Biotech Hunter