European journal of clinical pharmacology
Clinical safety, tolerability, and efficacy of fospropofol disodium for sedation: a systematic review
By Yan C, Jiao B, Xu X and 4 others.
Abstract
Purpose
Fospropofol disodium (fospropofol) is a water-soluble prodrug of propofol with a distinct pharmacological and tolerability profile. However, evidence regarding the safety, tolerability, and efficacy of fospropofol across broader sedation contexts and different comparators remains insufficiently synthesized. This systematic review summarized current research findings on fospropofol to clarify its clinical role and guide future research.
Methods
This systematic review was registered prior to initiation (PROSPERO CRD42023477740). Comprehensive searches were performed in PubMed, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, Embase via Ovid, ClinicalTrials.gov from inception to 26 August 2026. Randomized controlled trials (RCTs) evaluating fospropofol for sedation and reporting extractable efficacy or safety outcomes were eligible. Risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was evaluated according to the GRADE approach. Meta-analysis was performed for clinically comparable evidence groups, with other findings synthesized according to SWiM principles.