Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Proportion of patients with successful sedation at the start of ablation
研究概览
简要总结
The DEEP-PFA trial is an investigator-initiated, prospective, single-center, three-arm (1: 1: 1), randomized controlled study comparing three anesthesia regimens-midazolam + fentanyl (DS1), flurbiprofen + midazolam + fentanyl (DS2), and dexmedetomidine + midazolam + fentanyl (DS3)-for non-airway-assisted pulsed-field ablation (PFA) in atrial fibrillation (AF). Patients scheduled for atrial fibrillation ablation at Beijing Anzhen Hospital will be screened for eligibility. Following signature of informed consent, patients who meets all inclusion criteria without any exclusion criteria, will be randomly assigned at a 1:1:1 ratio to one of three groups: (1) DS1: Traditional Midazolam Group (Midazolam + Fentanyl); (2) DS2: Enhanced Analgesia Group (Flurbiprofen + Midazolam + Fentanyl); or (3) DS3: Enhanced Sedation Group (Dexmedetomidine + Midazolam + Fentanyl). The primary endpoint of this study was the proportion of patients achieving a Ramsay sedation score of ≥3 at the start of ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Diagnosis of paroxysmal or persistent atrial fibrillation with clinical indication for catheter ablation
- •Planned use of PFA as the ablation strategy
- •Ability and willingness to provide written informed consent
排除标准
- •Known hypersensitivity or allergy to study medications (fentanyl, midazolam, dexmedetomidine, flurbiprofen axetil)
- •Heart failure NYHA class III-IV
- •Severe obstructive sleep apnea syndrome
- •Severe respiratory disease, significant hepatic or renal dysfunction, advanced malignancy, or comorbidities with expected survival <1 year
- •Pregnancy or breastfeeding
- •Refusal to participate
- •Other circumstances deemed unsuitable for participation by the investigator
研究组 & 干预措施
Arm A (Fentanyl + Midazolam)
After venipuncture, patients receive intravenous midazolam 0.5 mg and fentanyl 20 µg, followed by continuous fentanyl infusion at 1-1.5 µg/kg/h. An additional 0.5 mg of midazolam is administered before interatrial septal puncture. After the start of ablation, fentanyl infusion is increased to 2.0-2.5 µg/kg/h. If needed, 0.5 mg of midazolam or 2 mL of fentanyl may be added.
干预措施: Arm A (Fentanyl + Midazolam) (Drug)
Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)
After venipuncture, patients receive midazolam 0.5 mg and fentanyl 20 µg intravenously, followed by a fentanyl infusion at 1-1.5 µg/kg/h. Prior to septal puncture, patients receive flurbiprofen axetil 50-100 mg and an additional 0.5 mg of midazolam. After ablation begins, fentanyl infusion is increased to 2.0-2.5 µg/kg/h. If needed, 0.5 mg of midazolam or 2 mL of fentanyl may be added.
干预措施: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) (Drug)
Arm C (Fentanyl + Dexmedetomidine)
Following femoral venous access, a loading dose of dexmedetomidine (1.0 µg/kg) was infused intravenously over 15 minutes. A maintenance infusion of 0.4 µg/kg/h was initiated thereafter (typically post-transseptal puncture). Fentanyl infusion commenced at venous access (1.0-1.5 µg/kg/h) and was increased to 2.0-2.5 µg/kg/h during ablation. Rescue boluses of midazolam (0.5 mg) or fentanyl (20-50 µg) were administered if required.
干预措施: Arm C (Fentanyl + Dexmedetomidine) (Drug)
结局指标
主要结局
Proportion of patients with successful sedation at the start of ablation
时间窗: At the initiation of ablation
The primary endpoint of this study was the proportion of patients achieving a Ramsay sedation score of ≥3 at the initiation of ablation. The Ramsay sedation scale is as follows: 1 indicates restlessness; 2 indicates fully awake, quiet, and cooperative; 3 indicates drowsy but responsive to verbal commands; 4 indicates lightly asleep but responsive to touch or pain; 5 indicates asleep but slowly responsive to touch or pain; and 6 indicates deeply asleep with no response.
次要结局
- Number of intraoperative interventions(perioperative period)
- Incidence of hypotension(Perioperative period)
- Incidence of hypoxemia(perioperative period)
- Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).(Perioperative period)
- Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).(perioperative period)
- Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain).(perioperative period)