Deep Sedation in Catheter Ablation of Atrial Fibrillation
NCT ID: NCT06836999
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1334 participants
INTERVENTIONAL
2025-03-03
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DS group
The CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic
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.
CS group
The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
* eGFR\<30mL/min/1.73㎡
* a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \[TIA\])
* acute or severe systemic infection
* intolerant to sedation or with a history suggestive of sleep apnea
* BMI \> 35 kg/㎡
* has contraindications to procedural sedation or refused to participate in this trial
* Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) \> 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g/L), or active bleeding
* pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
* life expectancy \< 12 months
* those who have participated in other clinical drug trials within 3 months prior to enrollment
* those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
* those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).
18 Years
75 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
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Principal Investigators
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Yunlong Xia, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Grimaldi M, Quadrini F, Caporusso N, Troisi F, Vitulano N, Delmonte V, Di Monaco A. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023 Aug 2;25(9):euad222. doi: 10.1093/europace/euad222.
Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/
Other Identifiers
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ChiCTR2500096790
Identifier Type: OTHER
Identifier Source: secondary_id
TEMP-000758
Identifier Type: -
Identifier Source: org_study_id
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