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

NCT06013345 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2025-02-03

No results posted yet for this study

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

DRUG

Remimazolam

analgosedation without secured airway

DRUG

Propofol

analgosedation with secured airway

DRUG

Propofol

TIVA with secured airway

Sponsors & Collaborators

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06013345 on ClinicalTrials.gov