New sedative may be safer for ICU patients on breathing machines
NCT ID NCT07536750
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two sedatives, ciprofol and propofol, given to ICU patients who need breathing support but are not on a ventilator. The goal is to see which drug works better and causes fewer breathing problems. About 1,680 adults from 30 hospitals in China will be included, and researchers will review past medical records to compare the drugs' safety and effectiveness.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,680 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510515, China
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