The Deep Sedation for Ablation Study

• Status: Completed
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Catheter ablation (CA) is an established therapeutic option for patients with symptomatic atrial fibrillation (AF). During the procedure, patients are usually sedated and analgesized, most commonly by administration of Propofol combined with opioids under the supervision of the electrophysiologist. However, due to the depressive effect of Propofol on the respiratory system, this regimen is not without risk. Dexmedetomidine is a highly selective alpha 2 agonist that demonstrates both analgesic and hypnotic properties with only weak effect on the respiratory system. The pharmacological profile of Dexmedetomidine may be advantageous for sedation during CA of AF. The aim of this randomized trial is to test this hypothesis and explore the safety and efficacy of Dexmedetomidine during CA of AF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

• Age ≥18 years

• Informed consent as documented by signature

• Catheter ablation of atrial fibrillation at the Department of Cardiology, Inselspital Bern

Exclusion Criteria:

• Contraindication to sedation by the electrophysiologist

• Contraindications to either propofol or dexmedetomidine sedation

• Contraindication for targeted controlled propofol infusion (BMI > 35)

• American Society of Anesthesiologists (ASA) classification > III

• Advanced heart block (second or third degree), if no pacemaker or internal cardioverter defibrillator is implanted

• Arterial hypotension (mean < 80 mmHg)

• Severe heart failure (LVEF ≤ 30%)

• Indication for general anaesthesia

• Pregnant or breast-feeding women