Sedation is frequently required in critically ill patients admitted to the intensive care unit (ICU), including those receiving non-invasive respiratory support such as high-flow nasal cannula (HFNC), non-invasive ventilation (NIV), or conventional oxygen therapy. Anxiety, agitation, dyspnea, and poor tolerance of respiratory support may compromise treatment adherence and increase the risk of respiratory deterioration and endotracheal intubation. Appropriate sedation may improve patient comfort, facilitate respiratory support, and reduce complications. However, sedation in non-mechanically ventilated ICU patients remains challenging because excessive sedation may lead to respiratory depression or hemodynamic instability.
Propofol is commonly used for ICU sedation because of its rapid onset and controllable depth of sedation. Nevertheless, propofol is associated with several adverse effects, including respiratory depression, hypotension, and injection pain, which may limit its use in patients without invasive mechanical ventilation.
Ciprofol is a novel short-acting intravenous sedative that acts as a gamma-aminobutyric acid type A (GABA-A) receptor agonist and is structurally related to propofol. Previous studies have demonstrated that ciprofol has rapid onset, predictable sedation, less injection pain, and a potentially lower incidence of respiratory depression and hemodynamic instability compared with propofol. Clinical studies have shown favorable safety and efficacy profiles of ciprofol in procedural sedation, anesthesia induction, and sedation in mechanically ventilated ICU patients. However, evidence regarding its use in ICU patients receiving non-mechanical ventilation is still limited.
This study aims to compare the effectiveness and safety of ciprofol versus propofol for sedation in adult ICU patients who are not receiving invasive mechanical ventilation. The study will be conducted as a multicenter retrospective cohort study involving approximately 30 tertiary hospitals in China. Adult ICU patients treated between January 1, 2022 and July 30, 2024 who received intravenous sedation with either ciprofol or propofol while receiving non-invasive respiratory support (including NIV, HFNC, or conventional oxygen therapy) will be included.
The primary outcomes are sedation success rate and the incidence of respiratory depression. Sedation success is defined as maintaining the Richmond Agitation-Sedation Scale (RASS) within the target range of -2 to +1 for at least two consecutive hours without discontinuation of the sedation regimen or switching to another sedative. Respiratory depression will be defined based on predefined criteria including severe hypoxemia, markedly reduced respiratory rate, abnormal end-tidal carbon dioxide levels, or apnea.
Secondary outcomes include endotracheal intubation rate during the sedation period, ICU length of stay, ICU mortality, and the requirement for vasoactive agents. Propensity score matching and multivariable statistical models will be used to adjust for baseline differences and potential confounders between treatment groups.
This real-world study aims to provide evidence regarding the clinical effectiveness and respiratory safety of ciprofol compared with propofol for sedation in ICU patients without invasive mechanical ventilation. The findings may help optimize sedation strategies in critically ill patients receiving non-invasive respiratory support and provide evidence to support future prospective clinical trials.
Age ≥18 years
Admitted to the intensive care unit (ICU) between January 1, 2022 and July 30, 2024
Received intravenous sedation with either ciprofol or propofol during ICU stay
Total duration of ciprofol or propofol administration ≥2 hours
Age <18 years
Pregnancy or breastfeeding
Use of other primary sedative agents during the observation period, including midazolam or dexmedetomidine
Total exposure time to ciprofol or propofol <2 hours
The study population will consist of patients admitted to intensive care units at multiple tertiary hospitals in China, including Southern Medical University Nanfang Hospital. Eligible patients who meet the predefined inclusion and exclusion criteria will be enrolled in the study.
Cohort
Retrospective
Not listed
Sedation Success Rate
Sedation success is defined as maintaining the Richmond Agitation-Sedation Scale (RASS) within the target range of -2 to +1 for at least 2 consecutive hours without premature discontinuation of the sedation regimen or switching to another sedative agent.
Incidence of Respiratory Depression
Respiratory depression is defined as the occurrence of any of the following events: respiratory rate ≤5 breaths/min for ≥3 minutes; peripheral oxygen saturation (SpO₂) ≤85% for ≥3 minutes; end-tidal carbon dioxide (EtCO₂) ≤15 mmHg or ≥60 mmHg for ≥3 minutes; or apnea lasting \>30 seconds.
Overall intubation rate
The proportion of patients who require endotracheal intubation during the sedation period for any clinical reason
Length of ICU Stay
Total duration of ICU hospitalization measured from ICU admission to ICU discharge or death
ICU Mortality
The proportion of patients who die during ICU hospitalization
Use of Vasoactive Agents
The intensity of vasoactive drug support quantified using the norepinephrine equivalent (NEE) dose
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