Comparison of Three Deep Sedation Strategies for Pulsed-Field Ablation

Capital Medical University

Status: Not yet enrolling

Conditions: Deep Sedation; Atrial Fibrillation (AF); PFA

Treatments: Drug: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam); Drug: Arm A (Fentanyl + Midazolam); Drug: Arm C (Fentanyl + Dexmedetomidine)

Study type: Interventional

Funder types: Other

Identifiers

NCT07149545

Three Deep Sedation Strategies

Details and patient eligibility

About

This prospective, randomized, parallel, single-center study aims to evaluate the effectiveness and safety of three deep sedation strategies in patients undergoing pulsed-field ablation (PFA) for atrial fibrillation (AF). The primary endpoint is the proportion of patients achieving adequate sedation (Ramsay sedation score ≥3) during ablation. Secondary outcomes include intraoperative sedation difficulty, operator satisfaction, patient recall of intraoperative pain, perioperative hemodynamic events, and the need for intraoperative interventions.

Enrollment: 180 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Age ≥18 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Arm A (Fentanyl + Midazolam)

Experimental group

Description:

Sedation protocol: Fentanyl infusion (0.1 mL/kg/h) initiated after surgical site disinfection; during ablation, fentanyl 2 mL and midazolam 0.5 mg were administered intravenously. Additional fentanyl or midazolam was given if needed.

Treatment:

Drug: Arm A (Fentanyl + Midazolam)

Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)

Experimental group

Description:

Sedation protocol: Fentanyl infusion (0.1 mL/kg/h) initiated after disinfection; flurbiprofen axetil (100 mg) administered intravenously after transseptal puncture; fentanyl 2 mL and midazolam 0.5 mg administered during ablation. Additional fentanyl was given if needed.

Treatment:

Drug: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)

Arm C (Fentanyl + Dexmedetomidine)

Experimental group

Description:

Sedation protocol: Fentanyl infusion (0.1 mL/kg/h) initiated after disinfection; dexmedetomidine continuous infusion (0.4 μg/kg/h) was administered throughout.

Treatment:

Drug: Arm C (Fentanyl + Dexmedetomidine)