Ciprofol versus propofol for sedating adult ICU patients on noninvasive respiratory support
Comparison of the Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients Undergoing Non-Invasive Ventilation: A Multicenter Retrospective Cohort Study
See if ciprofol works better than propofol for sedating adults in the ICU who are receiving noninvasive ventilation, high-flow nasal cannula, or oxygen therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1680 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07536750 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational comparison of adults admitted to the ICU at Nanfang Hospital who received intravenous ciprofol or propofol for sedation while not invasively ventilated. Researchers will use electronic medical records from Jan 1, 2022 to Jul 30, 2024 to compare sedation depth (RASS), vital signs, respiratory events, hemodynamic instability, and need for escalation to endotracheal intubation. Patients must have received at least two hours of the index sedative and have continuous monitoring and complete sedation assessments. Safety endpoints will focus on respiratory depression, hypoxemia, hypotension, and sedation-related adverse events in the non-intubated ICU population.
Who should consider this trial
Good fit: Adults (≥18) admitted to the ICU at Nanfang Hospital between Jan 1, 2022 and Jul 30, 2024 who received at least two hours of intravenous ciprofol or propofol while on noninvasive ventilation, high-flow nasal cannula, or other oxygen therapy with complete RASS and continuous vital sign records.
Not a fit: Patients who are invasively ventilated, under 18, pregnant or breastfeeding, predominantly given other sedatives, or who lack complete sedation and monitoring records are unlikely to be included or to benefit from these findings.
Why it matters
Potential benefit: If ciprofol provides effective sedation with fewer respiratory or cardiovascular side effects, patients may tolerate noninvasive respiratory support better and have fewer emergency intubations.
How similar studies have performed: Propofol is well established for ICU sedation, whereas ciprofol is a newer agent with promising anesthesia data but limited comparative real-world ICU evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Age: * 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 Exclusion Criteria: * 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) * Any condition that the investigators consider inappropriate for inclusion in the study
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: zhenhua zeng, doctor
- Email: hzengzhu@163.com
- Phone: +86 18529269527
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.