Deep Sedation in Catheter Ablation of Atrial Fibrillation

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 punct
• Процедура 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.

Первичные конечные точки

• Rhythm outcomes [Срок оценки: 4-12month post-ablation]

Вторичные конечные точки (7)

• Score of patients' intraprocedural experiences [Срок оценки: during the CA procedure]
• Score of ablators', staffs',nurse's intraprocedural experiences [Срок оценки: during the CA procedure]
• respiratory system safety outcome [Срок оценки: From the start of sedation to the end of the procedure]
• Rate of re-ablation acceptances [Срок оценки: 4-12month post-ablation]
• Procedure time [Срок оценки: during the CA procedure]
• The dosage of painkillers [Срок оценки: during the CA procedure]
• the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway [Срок оценки: From the start of sedation to the end of the procedure]

Критерии участия

Критерии включения

● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure

Критерии исключения

• has received CA procedure for AF or atrial septal defect repair before enrollment
• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 16 центров

• Anhui Provincial Hospital — Хэфэй
• Guangdong Provincial People's Hospital — Гуанчжоу
• NanFang Hospital — Гуанчжоу
• Jiangsu Provincial Hospital — Нанкин
• The First Affiliated Hospital of Soochow University — Сучжоу
• The First Affiliated Hospital of Nanchang University — Nanchang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• First Affiliated Hospital of Dalian Medical University — Dalian
• … и ещё 8 центров

Публикации

• 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. PMID 37470452
• Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/ PMID 31869149

Идентификаторы

NCT: NCT06836999 · TEMP-000758 · ChiCTR2500096790

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)
• ChiCTR ChiCTR2500096790 (Китайский реестр КИ)

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