Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients

Phase 2 Unknown 60 enrolled Xiaobo Yang, MD

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated ICU patients.

Timeline

Start: 2023-06-01
Primary completion: 2024-03-01
Completion: 2024-06-01

Outcome

Missed primary endpoint

paper 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). PMID 40211146 ↗

Publications

Gao X, Gao C, Fang X, Ren L, Zhang H, Tang Y, Yuan Y, Qi H, Shu H, Zou X, Yang X, Shang Y. Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study. BMC Anesthesiol. 2025 Apr 10;25(1):166. doi: 10.1186/s12871-025-03025-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Propofol	Small molecule	3 mg/kg	—
Subject	fospropofol	Small molecule	10 mg/kg	—

Indications

No indication recorded.