0000000000730449

AUTHOR

Matthias Drüner

Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial.

Summary Background Previous studies indicate that isoflurane could be useful for the sedation of patients in the intensive care unit (ICU), but prospective studies evaluating isoflurane's efficacy have been small. The aim of this study was to test whether the sedation with isoflurane was non-inferior to sedation with propofol. Methods This phase 3, randomised, controlled, open-label non-inferiority trial evaluated the efficacy and safety of up to 54 h of isoflurane compared with propofol in adults (aged ≥18 years) who were invasively ventilated in ICUs in Germany (21 sites) and Slovenia (three sites). Patients were randomly assigned (1:1) to isoflurane inhalation via the Sedaconda anaesthet…

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A Randomized Controlled Trial Comparing Inhaled Isoflurane Via the Anaesthetic Conserving Device (Sedaconda <sup>®</sup> ACD) with Propofol for Sedation of Invasively Ventilated ICU Patients

Background: Small studies indicate that isoflurane may be useful for sedation during invasive ventilation of ICU patients. There are no published large prospective efficacy trials. Methods: This phase 3, non-inferiority trial evaluated the efficacy and safety of ≤54 hours of isoflurane via the anaesthetic conserving device (ACD) compared with propofol in invasively ventilated ICU patients (30-day follow-up). Primary endpoint was percentage of time in Richmond Agitation–Sedation Scale (RASS) range –1 to –4; the predefined non-inferiority margin was 15% below the propofol mean. Secondary endpoints: opioid requirements, spontaneous breathing during sedation, time to wake-up and extubation, adv…

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