Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study.

Background: Fospropofol disodium is comparable to propofol in maintaining mild-to-moderate sedation for mechanically ventilated patients in intensive care unit (ICU). However, its efficacy for deep sedation remains unclear. Therefore, we conducted a randomized-controlled trial comparing the efficacy and safety of fospropofol disodium with propofol for deep sedation of mechanically ventilated patients in ICU.

Methods: In this randomized pilot study, critically ill adult patients requiring deep sedation were randomized to receive fospropofol disodium or propofol. The study drug was titrated to maintain a Richmond Agitation-Sedation Scale score (RASS) of-5 or-4. Narcotrend Index (NI) value was monitored during the whole study period. The primary outcome was the percentage of time in the target sedation range without rescue sedation. The secondary outcomes were successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, 28-day all-cause mortality and adverse events.

Results: Thirty patients were included in each group. The fospropofol disodium infusion lasted for 47.50 (IQR 31.75 to 48.00) hours at a dose of 8.19 ± 2.36 mg/kg/h, while propofol infusion for 48.00 (IQR 30.88 to 48.00) hours at 2.73 ± 0.83 mg/kg/h. The proportion of time within the target RASS range without rescue sedation was 96.78%±0.07% in the fospropofol group and 98.43%±0.04% in the propofol group (p = 0.273). A total of 39 patients experienced adverse events, with 19 in the fospropofol group and 20 in the propofol group. The most common adverse event was hypotension, with 18 patients (60.0%) in each group. No significant differences were observed in successful extubation, ventilator-free days at day 7, ventilator-free days at day 28, or 28-day all-cause mortality.

Conclusions: In this open-label trial, fospropofol disodium achieved deep sedation at a rate comparable to propofol. For mechanically ventilated ICU patients, fospropofol disodium may offer a safe and effective sedation option. Larger multicenter trials are needed to confirm these findings.

Trial Registration: The trial was registered on ClinicalTrials.gov on May 12, 2023, with the identifer NCT05870514.