Trials / Completed
CompletedNCT06013345
COnventional Vs. Optimised PERiprocedural Analgosedation Vs. Total IntraVEnous Anaesthesia for Pulsed-Field Ablation (COOPERATIVE-PFA)
Conventional Vs. Optimised Periprocedural Analgosedation Vs. Total Intravenous Anaesthesia for Pulsed-field Ablation: a Randomised Controlled Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Charles University, Czech Republic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remimazolam | analgosedation without secured airway |
| DRUG | Propofol | analgosedation with secured airway |
| DRUG | Propofol | TIVA with secured airway |
Timeline
- Start date
- 2023-10-25
- Primary completion
- 2024-09-30
- Completion
- 2024-12-01
- First posted
- 2023-08-28
- Last updated
- 2025-02-03
Locations
1 site across 1 country: Czechia
Source: ClinicalTrials.gov record NCT06013345. Inclusion in this directory is not an endorsement.