drugset / Trial / NCT06013345
COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |