Atrial Fibrillation (AF), Deep Sedation, PFA
Conditions
Brief summary
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.
Interventions
DRUGArm A (Fentanyl + Midazolam)
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.
DRUGArm B (Flurbiprofen axetil + Fentanyl + Midazolam)
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.
DRUGArm C (Fentanyl + Dexmedetomidine)
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.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years 2. Diagnosis of paroxysmal or persistent atrial fibrillation with clinical indication for catheter ablation 3. Planned use of PFA as the ablation strategy 4. Ability and willingness to provide written informed consent
Exclusion criteria
1. Known hypersensitivity or allergy to study medications (fentanyl, midazolam, dexmedetomidine, flurbiprofen axetil) 2. Heart failure NYHA class III-IV 3. Severe obstructive sleep apnea syndrome 4. Severe respiratory disease, significant hepatic or renal dysfunction, advanced malignancy, or comorbidities with expected survival \<1 year 5. Pregnancy or breastfeeding 6. Refusal to participate 7. Other circumstances deemed unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with successful sedation at the start of ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of hypotension | Perioperative period | Defined as a mean arterial pressure (MAP) \<65 mmHg or a ≥20% reduction from baseline. |
| Incidence of hypoxemia | perioperative period | Defined as SpO₂ \<90% lasting for over 10 s. |
| Number of intraoperative interventions | perioperative period | Number of intraoperative interventions (oxygen adjustment, hemodynamic drugs, airway management, conversion to general anesthesia) |
| Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied). | Perioperative period | 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). |
| Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied). | perioperative period | 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). |
| Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain). | perioperative period | Intraoperative pain intensity: Measured postoperatively based on patient recall using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst imaginable pain). |
Countries
China
Outcome results
None listed