Exploration of the effects of fospropofol disodium in anesthesia induction for elderly hip surgery: A study protocol for a Clinical Trial

Background. Fospropofol disodium is a novel water-soluble prodrug of propofol. This randomized controlled trial aimed to compare the efficacy and safety of fospropofol disodium versus etomidate for anesthesia induction in elderly patients undergoing hip surgery. Methods and analysis. This single-center, randomized, double-blind, controlled trial. It will enroll 120 elderly patients scheduled for hip surgery. Participants will be randomized in a 1:1 ratio to either the fospropofol disodium group (Group P) or the etomidate group (Group E). All patients will receive intravenous anesthesia induction with either fospropofol disodium or etomidate, according to their randomized group assignment. We will collect the following data，including: the time to loss of consciousness；the success rate of anesthesia induction; the incidence of injection pain, myoclonus, and sensory abnormalities within 30 seconds after initial dose administration; intraoperative hemodynamic stability; total intraoperative consumption of opioids, propofol, and vasoactive drugs; postoperative recovery time; the incidence of postoperative nausea and vomiting within 48 hours postoperatively; the incidence of postoperative delirium within 48 hours postoperatively; and serum high-sensitivity troponin T (hs-TnT) levels within 48 hours postoperatively. Data will be analyzed on an intention-to-treat basis and Per Protocol Analysis. Discussion We hypothesized that: fospropofol disodium would be clinically effective for anesthesia induction in elderly hip surgery patients; its hemodynamic stability would be non-inferior to etomidate; and it would demonstrate a superior safety profile with fewer adverse effects compared to etomidate. Clinical trial registration : The UK’s Clinical Study Registry ( ISRCTN registry ) https://www.isrctn.com/ISRCTN12170320 registration number: ISRCTN12170320 Date:01/07/2025