drugset / Trial / NCT03844841

The Deep Sedation for Ablation Study

NCT03844841 ↗

Phase 4 Completed 160 enrolled Insel Gruppe AG, University Hospital Bern
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2019-07-01
Primary completion
2020-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.4 ug/kg Intravenous
Comparator Propofol Small molecule 1 ug/ml Intravenous

Indications