Clinical safety, tolerability, and efficacy of fospropofol disodium for sedation: a systematic review.

In 30 seconds

This systematic review and meta-analysis assessed randomized trials of fospropofol for procedural and ICU sedation. It included 10 studies: six procedural-sedation trials and four ICU-sedation trials. In three endoscopic trials, sedation success was higher with fospropofol 6.5 mg/kg than with 2 mg/kg (RR 3.27, 95% CI 2.62-4.08). In mechanically ventilated ICU patients, hypotension risk did not clearly differ between fospropofol and propofol (RR 0.93, 95% CI 0.67-1.28). Overall, efficacy and safety varied by dose, comparator, and setting, with no consistent cardiorespiratory safety advantage established.

Key findings

• In three endoscopic trials, fospropofol 6.5 mg/kg achieved greater sedation success than 2 mg/kg (RR 3.27, 95% CI 2.62-4.08).
• Among mechanically ventilated ICU patients, hypotension risk did not clearly differ between fospropofol and propofol (RR 0.93, 95% CI 0.67-1.28).
• Paresthesia and pruritus were commonly reported; cardiorespiratory adverse events showed no consistent comparative advantage for fospropofol.
• Certainty of evidence ranged from high to very low, mainly because of risk of bias and imprecision.

Why it matters

Sedation efficacy and adverse effects may depend on the clinical setting, dose, and comparator, so results from procedural sedation should not be assumed to apply to ICU care. The review finds a dose-related efficacy signal in endoscopy but does not establish a consistent cardiorespiratory safety advantage over other sedatives. This helps frame fospropofol’s potential role while highlighting uncertainty in comparative safety.

What to keep in mind

Only 10 trials were included, and quantitative synthesis was possible for two comparable evidence groups. Evidence certainty varied, with risk of bias and imprecision limiting confidence.