drugset / Trial / NCT06013345

COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)

NCT06013345

Phase 3 Completed 127 enrolled Charles University, Czech Republic
RandomizedParallel-groupSingle-blindTreatment

Summary

A prospective single blinded (subject blinded) 1:1:1 randomised control trial with three parallel arms testing superiority of analgosedation regimen based on remimazolam and total intravenous anesthesia over propofol based analgosedation. The primary composite endpoint consists of hypoxaemia, hypotension, or hypertension requiring intervention.

Timeline

Start
2023-10-25
Primary completion
2024-09-30
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule 3 ug/ml
Comparator Propofol Small molecule 5 ug/ml
Comparator Propofol Small molecule 0.5 mg/kg
Subject Remimazolam Small molecule 0.5 mg/kg

Indications