Trial intelligence / Profile preview

Isoflurane vs Propofol for Sedation in Mechanically Ventilated ICU Patients

NCT05312385Phase 3

Key facts

Status: Completed
Start: Apr 2022
Primary completion: Apr 2024
Countries: 1
Sponsor: Sedana Medical
Modality: Allosteric Modulators

Drugs: isoflurane
Conditions: sedation

Overview

Phase 3, randomised, single-blind trial of isoflurane in sedation (2 arms), sponsored by Sedana Medical. Primary endpoint: Percentage of Time Sedation Depth is Maintained Within the Target Range up to 48 hours. Started Apr 2022; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

Isoflurane
Inhaled isoflurane administered via Sedaconda ACD-S
Propofol
Propofol administered as intravenous infusion

Who it enrols

Adult ICU patients requiring >12 hours of invasive mechanical ventilation and continuous sedation to RASS <0, excluding those with severe neurological conditions, severe hemodynamic compromise, or requiring ECMO/HFOV.

Endpoints

Primary

Percentage of Time Sedation Depth is Maintained Within the Target Rangeup to 48 hours

Secondary

Use of Opioids During the Study Treatment Periodup to 48 hours
Wake up Time at End of Study Drug Treatmentup to 4 hours post-treatment
Cognitive Recovery After End of Study Drug Treatment60 minutes post-treatment
Spontaneous Breathing Effort During the Study Drug Treatment Periodup to 48 hours
Time From Sedation Termination to Extubationup to 7 days
Days Alive and Free of Mechanical Ventilation Through Study Day 3030 days
Days Alive and Free of the ICU30 days
Delirium and Coma Free Days Until 7 Days After End of Study Treatmentup to 9 days

Results

Primary endpoints met

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