Abstract
OBJECTIVE: To evaluate whether fospropofol disodium can be safely and effectively used for goal-directed sedation in mechanically ventilated intensive care unit (ICU) patients. METHODS: A prospective, open-label, randomized controlled pilot trial was conducted. The subjects were randomly divided into groups at a 1:1:1 ratio and received treatment with fospropofol disodium, propofol or midazolam. This study adopted a random grouping method and was simulated using SAS software. Researchers who participated in this study screened each eligible subject, logged their data into the randomization system, filled in the subject screening information, and obtained the randomization number and corresponding drug number. Patients who were expected to require mechanical ventilation for more than 24 h and receive analgesic and sedative medications in the intensive care unit of the Second Hospital of Lanzhou University from August 2024 to June 2025 were selected for inclusion in our study. Pregnant or lactating women; those with allergies to the trial drugs or contraindications to opioid use; and those with severe craniocerebral injury, brain tumors, increased intracranial pressure, or conditions prone to respiratory depression were excluded. On the basis of the different sedation protocols, the patients were divided into the fospropofol disodium group (FP group), the propofol group (P group), and the midazolam group (M group). A target-driven titration strategy was applied; both drugs were titrated to achieve the same target (Richmond Agitation–Sedation Scale (RASS) score of -2). General demographic data, routine blood test results, inflammatory marker (IL-6, IL-8, and TNF-a) levels, arterial blood gas analysis results, and mechanical ventilation parameters were recorded at admission. RESULTS: In accordance with the inclusion and exclusion criteria, a total of 212 patients who required mechanical ventilation (MV) were initially enrolled. Two patients were excluded because their admission time was less than 24 h, which resulted in a final sample of 210 patients. Our study revealed that the duration of mechanical ventilation was 8.6 ± 2.09 days, 8.71 ± 2.44 days, and 12.23 ± 2.13 days in the FP, P and M groups, respectively. The length of ICU stay was 10.57 ± 2.69 days, 10.69 ± 2.79 days, and 13.84 ± 2.45 days in the FP, P and M groups, respectively. Significant differences were observed between the groups. The incidence of delirium was 7/70, 9/70, and 21/70 in the FP, P and M groups, respectively. The incidence of hypotension was 8/70, 16/70, and 10/70 in the FP, P and M groups, respectively. Significant differences were noted between the groups. CONCLUSION: The use of fospropofol disodium in mechanically ventilated patients in the ICU may be safe, and its feasibility was explored in this pilot trial. However, since the majority of the included patients had sepsis, future studies should be conducted in a broader range of patient populations to further validate the efficacy and safety of fospropofol disodium.