New sedative aims to keep ICU patients calm without dropping blood pressure
NCT ID NCT06538883
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study compares a new sedative called ciprofol to the standard drug propofol in 366 ICU patients who need a breathing tube. The goal is to see if ciprofol can sedate patients just as well but with fewer episodes of dangerously low blood pressure. Participants will be randomly assigned to receive one of the two drugs, and neither they nor their doctors will know which one they are getting.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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366 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Apr 2026
- 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.
- Ages
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18 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria (patients who met all the following criteria): 1. Adults are sequentially admitted to ICU undergoing mechanical ventilation; Patients are expected to need 6-24 hours of sedation for the target RASS ranged from +1 to -2 after randomization; 2. Aged ≥ 18 and ≤ 80 years old, with no gender requirement; 3. The patients or their family members fully understood the objectives and significance of this study and voluntarily participated and signed informed consent forms. Exclusion criteria (patients who met 1 of the following criteria were excluded): 1\. Patients known to be allergic or contraindicated to ciprofol. 2. BMI\<18 kg/m2 or \>30 kg/m2. 3. Patients who had received sedation for more than 3 days in an ICU or in a general ward prior to being transferred to the ICU before signing an informed consent form. 4\. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk: 1. Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; patients who required vasopressor (equivalent norepinephrine ≥ 1μg/kg/min) to maintain a normal blood pressure. 2. Patients with hepatic and renal failure (liver function: refer to Child-Pugh grade C; renal function: eGFR ≤ 30 mL/(min·1.73 m2) \[eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr) - 1.234 × age - 0.179 × 0.79 (females)\]; patients undergoing dialysis. 3. Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points. 5\. Patients with an expected survival of ≤ 24 h. 6. Pregnant or lactating females. 7. Patients participated in other drug clinical trials before screening. 8. Other conditions that patients were judged by the investigator to be unsuitable for inclusion in the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.
Nanjing, Jiangsu, 210009, China
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