An interventional study of Arm A (Fentanyl + Midazolam) and Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) in Atrial Fibrillation (AF), PFA and Deep Sedation, sponsored by Beijing Anzhen Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment
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.
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Exclusion criteria:
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.
Drug: Arm A (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.
Drug: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)
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.
Drug: Arm C (Fentanyl + Dexmedetomidine)
Prior to venous puncture, administer 0.5 mg midazolam intravenously, concurrently with 20 µg fentanyl intravenously. Subsequently, maintain fentanyl infusion at 1-1.5 µg/kg/h. Prior to atrial septal puncture, administer an additional 0.5 mg midazolam. Upon initiation of ablation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, supplement with 0.5 mg midazolam or 2 ml fentanyl.
Prior to venous puncture, administer 0.5 mg midazolam intravenously, followed by 20 µg fentanyl intravenously. Subsequently, maintain fentanyl infusion at 1-1.5 µg/kg/h. Prior to atrial septal puncture, administer 50-100 mg flurbiprofen ester and 0.5 mg midazolam. Upon ablation initiation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, supplement with 0.5 mg midazolam or 2 ml fentanyl.
Prior to venous puncture, administer dexmedetomidine intravenously at 1 µg/kg/h for 15 minutes, then reduce to 0.4 µg/kg/h. Concurrently, administer fentanyl intravenously at 20 µg. Subsequently, maintain dexmedetomidine infusion at 1-1.5 µg/kg/h. After ablation initiation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, administer an additional 0.5 mg midazolam or 2 ml fentanyl.
Proportion of patients with successful sedation at the start 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.
Time frame: At the initiation of ablation
Incidence of hypotension
Defined as a mean arterial pressure (MAP) \<65 mmHg or a ≥20% reduction from baseline.
Time frame: Perioperative period
Incidence of hypoxemia
Defined as SpO₂ \<90% lasting for over 10 s.
Time frame: perioperative period
Number of intraoperative interventions
Number of intraoperative interventions (oxygen adjustment, hemodynamic drugs, airway management, conversion to general anesthesia)
Time frame: perioperative period
Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
Rated by the operating electrophysiologist on a 5-point Likert scale (1 = not difficult, 2 = mildly difficult, 3 = moderately difficult, 4 = very difficult, 5 = extremely difficult).
Time frame: Perioperative period
Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
Operator satisfaction (5-point Likert scale): Rated postoperatively by the operating electrophysiologist on a 5-point Likert scale (1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).
Time frame: perioperative period
Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain).
Intraoperative pain intensity: Measured postoperatively based on patient recall using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst imaginable pain).
Time frame: perioperative period
Plan to share: No
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Beijing Anzhen Hospital