Comparison of the Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients Undergoing Non-Invasive Ventilation

NCT07536750 | Recruiting

• 1 other identifier: NFEC-2025-549
• Study Type: observational
• Target: 1,680
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure; Critical Illness

Keywords

Ciprofol; Propofol; ICU Sedation; Noninvasive Ventilation; High-Flow Nasal Cannula; Respiratory Depression; Sedation Safety; Critical Care

Outcome Measures

Primary Outcomes (2)

• 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.

  From initiation of sedation up to 72 hours during ICU stay.

• 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.

  From initiation of sedation up to 72 hours during ICU stay.

Secondary Outcomes (4)

• Overall intubation rate

  From initiation of sedation to ICU discharge or death, whichever occurs first (up to 28 days)

• Length of ICU Stay

  From ICU admission to ICU discharge or death, whichever occurs first (up to 28 days)

• ICU Mortality

  From ICU admission to ICU discharge or death, whichever occurs first (up to 28 days)

• Use of Vasoactive Agents

  During the sedation observation period (up to 72 hours)

Study Arms (2)

Ciprofol Sedation Group

Adult ICU patients without invasive mechanical ventilation who received intravenous ciprofol for sedation during ICU treatment.

Propofol Sedation Group

Adult ICU patients without invasive mechanical ventilation who received intravenous propofol for sedation during ICU treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• Sedation initiated while the patient was not receiving invasive mechanical ventilation
• Receiving non-invasive respiratory support or oxygen therapy at the time sedation was started, including noninvasive ventilation (NIV), high-flow nasal cannula (HFNC), nasal cannula, or face mask oxygen therapy
• Availability of complete electronic medical records including sedation assessment using the Richmond Agitation-Sedation Scale (RASS)
• Availability of continuous vital sign monitoring records including respiratory rate, oxygen saturation, blood pressure, and heart rate

You may not qualify if:

• 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
• Known allergy or hypersensitivity to ciprofol, propofol, or their formulation components
• Initiation of invasive mechanical ventilation before sedation
• Missing key clinical data required for outcome evaluation, including sedation score, vital signs, or drug administration records
• Participation in other interventional clinical trials that may interfere with outcome assessment
• Severe visual or hearing impairment preventing accurate sedation assessment
• Coma or conditions that prevent reliable evaluation using the Richmond Agitation-Sedation Scale (RASS)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

zhenhua zeng, doctor

CONTACT

+86 18529269527; hzengzhu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)