Conclusions
During procedural sedation, fospropofol disodium may reduce injection pain and respiratory adverse events and may lower the risk of hypotension compared with propofol. This hypotension benefit should not be extrapolated to the ICU. During continuous ICU sedation no data were available for injection pain or respiratory adverse events, so the safety evidence in that setting remains limited. Hypertriglyceridaemia was lower only under the DerSimonian-Laird model. Because the result depends on the method and certainty is very low, it cannot be treated as definitive. The main cost is a clear increase in pruritus and abnormal sensations. Onset may be slower, but the evidence comes from two bolus-dosing studies in procedural sedation, and no such disadvantage was seen during continuous ICU infusion. Evidence on sedation efficacy, recovery time, discharge time and successful extubation is limited, and equivalence between the two drugs cannot be asserted. Because most studies were small and open-label and certainty ranged from very low to moderate, these findings support investigational use only and do not justify a routine clinical recommendation.
Evidence before this study: We searched Europe PMC, PubMed, Embase, Cochrane CENTRAL, Web of Science Core Collection and Chinese databases (CNKI, Wanfang, VIP) by crossing drug terms (fospropofol, fospropofol disodium, Lusedra, Aquavan) with sedation setting terms (ICU, mechanical ventilation, endoscopy, gastroscopy, hysteroscopy, bronchoscopy, procedural sedation). Within the retrieved literature, the only relevant meta-analysis addressed general anaesthesia induction; no synthesis of the sedation setting was identified.
Added value of this study: The present synthesis focuses on sedation outside the operating room, includes 12 RCTs, and stratifies by setting. It reports eight safety and efficacy outcomes (recovery time and other continuous outcomes are reported narratively), together with heterogeneity, leave-one-out sensitivity analysis, trial sequential analysis and GRADE certainty, and it quantifies the costs of fospropofol disodium (pruritus/paraesthesia; slower onset after bolus dosing).
Clinical implications: Fospropofol disodium may reduce injection pain during sedation. For hypertriglyceridaemia the result depends on the estimator and certainty is very low. During procedural sedation it may reduce hypotension and respiratory adverse events, whereas the evidence for a hypotension benefit during continuous ICU sedation is weak. Because the approved indication in China is adult general anaesthesia induction only, these uses remain investigational; they do not constitute a routine clinical recommendation. Applicability to specific patient groups remains an inference from pharmacological mechanism.
