SedationPhase 4NCT06538883
Sedation in ICU Patients With Mechanical Ventilation
A Phase 4 study testing Ciprofol and Sedation with Propofol in people with Sedation and Mechanical Ventilation, run by Zhongda Hospital at 1 site in China.
Trial summary
Background: Sedation is a cornerstone of management for mechanically ventilated patients in the intensive care unit (ICU). Achieving early target sedation while maintaining hemodynamic stability remains a major clinical challenge. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation, Mechanical Ventilation
- What is being tested?
- Ciprofol and Sedation with Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria (patients who met all the following criteria):
- 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;
- Aged ≥ 18 and ≤ 80 years old, with no gender requirement;
- 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):
- 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.
- Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:
- 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.
- 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.
- Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongda Hospital, Southeast University, No. 87, Dingjiaqiao Road, Gulou District, Nanjing, 210009, People's Republic of China.
Nanjing, Jiangsu, 210009
About this study
Official title: Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial
Background: Sedation is a cornerstone of management for mechanically ventilated patients in the intensive care unit (ICU). Achieving early target sedation while maintaining hemodynamic stability remains a major clinical challenge. Ciprofol, a novel intravenous sedative agent structurally derived from propofol, has shown promising efficacy and a potentially improved hemodynamic profile in preclinical and phase II/III studies. However, high-quality evidence from large, multicenter randomized trials in real-world ICU settings is lacking.
Objective: To evaluate the efficacy and safety of ciprofol versus propofol for sedation in mechanically ventilated ICU patients, as assessed by the incidence of early successful sedation without hypotension.
Read more
Methods: This is a multicenter, randomized, double-blind, parallel-group, active-controlled, noninferiority clinical trial conducted across 31 centers in China. A total of 366 patients will be randomized in a 1:1 ratio to receive either ciprofol or propofol. Eligible patients are adults (aged 18-80 years) admitted to the ICU receiving mechanical ventilation, with an expected sedation duration of 6-24 hours and a target Richmond Agitation-Sedation Scale (RASS) of +1 to -2. Key exclusion criteria include known allergy to ciprofol, BMI <18 or >30 kg/m², prior sedation for >3 days, severe cardiovascular, hepatic or renal dysfunction, Glasgow Coma Scale ≤12, expected survival ≤24 hours, pregnancy or lactation, and participation in other drug trials.
Patients will receive a loading dose (ciprofol 0.1 mg/kg or propofol 0.5 mg/kg) over 4 minutes, followed by a maintenance infusion titrated to achieve the target RASS. Remifentanil will be used for analgesia throughout. The primary composite outcome is successful sedation without hypotension within 30 minutes of study drug administration, defined as: (1) RASS within the target range of +1 to -2; (2) no use of rescue sedation; and (3) no occurrence of hypotension. Hypotension is defined as systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, mean arterial pressure <70 mmHg, or a >30% drop from baseline. Secondary outcomes include sedation success without hypotension at 1 hour, sedation without circulatory depression (hypotension or bradycardia) at 1 hour, drug utilization, duration of mechanical ventilation, extubation time, awakening time, delirium incidence (CAM-ICU), ICU length of stay, 28-day mortality, and safety profiles.
Based on an assumed 92% incidence in the ciprofol group versus 82% in the propofol group, with a two-sided alpha of 0.05 and 80% power, and allowing for a 5% dropout rate, the required sample size is 183 patients per group, totaling 366 patients. Analysis will be performed on the intention-to-treat population using logistic regression for the primary outcome, with results expressed as risk difference and relative risk with 95% confidence intervals.
Ethics and Dissemination: The study protocol has been approved by the ethics committee of the coordinating center and will be submitted to all participating sites. The trial is registered with ClinicalTrials.gov (NCT06538883). Results will be disseminated through peer-reviewed publications and academic presentations.
Keywords: Ciprofol, Propofol, Intensive care unit, Mechanical ventilation, Sedation, Hypotension, Randomized controlled trial
- Conditions
- Sedation, Mechanical Ventilation
- Being tested
- Ciprofol, Sedation with Propofol
- Keywords
- Sedation, Mechanical Ventilation, ICU, Ciprofol, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
During the drug administration period, ciprofol were IV infused at loading doses of 0.1 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.
Sedation with PropofolDrug
During the drug administration period, propofol were IV infused at loading doses of 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Propofol were then immediately administered at an initial maintenance dose of 1.5 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol | Experimental | Not described Receives: Drug: Ciprofol |
| Propofol | Active comparator | Not described Receives: Drug: Sedation with Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the rate of successful sedation without hypotension
The primary outcome is the rate of successful sedation without hypotension, which have to meet the following three criteria simultaneously: 1) Sedation within the RASS target (+1 to -2); 2) No rescue therapy is used; 3) No hypotension occurs, within the first 30 minutes of administering the study drug.
Measured: within the first 30 minutes of administering the study drug
Secondary outcomes (11)
the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;
Measured: within the first 1hour of administering the study drug
the rate of within sedation target (RASS: +1 to -2) without circulatory inhibition (defined as either hypotension or bradycardia) in the first 1hour of administering the study drug;
Measured: within the first 1hour of administering the study drug
Usage of study drugs
the total additional dose will be recorded;
Measured: within the first 24hours of administering the study drug
Duration of mechanical ventilation
Duration of mechanical ventilation: defined as the time from randomization to extubation in 28 days
Measured: from randomization until the date of first extubation or date of death from any cause, whichever came first, assessed up to 28 days
Extubation time
defined as time from stopping the study drug to extubation, or death from any cause; not applicable for patients who withdraw early or do not plan to extubate after stopping the drug, in 28 days;
Measured: from stopping the study drug to extubation, or death from any cause, or 28 days
Awakening time
defined as the time from stopping the study drug to awakening from sedation (RASS ≥ 0) in 24h after stopping the drug. If RASS is ≥ 0 at the time of stopping the drug, the awakening time is recorded as 0; If RASS is less than 0 in 24h after stopping the drug, the awakening time is recorded as 24h;
Measured: from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 24h after stopping the drug.
Incidence of delirium
Incidence of delirium, which is assessed using the CAM-ICU;
Measured: from administation of study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days
Length of ICU stay
defined as the time from randomization to discharge from the ICU;
Measured: the time from randomization to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days
The 28-day mortality
all caused mortality within 28 days.
Measured: from randomization to 28 days
Incidence of hypotension
Hypotension was defined as SBP < 90 mmHg, or DBP < 60 mmHg, or MAP < 70 mmHg, or a drop of more than 30% from baseline, or as determined by the investigator; and the use of vasopressor medications will be recorded;
Measured: from randomization to 48 hours after the end of study drug administration
Incidence of bradycardia
HR < 40 bpm or a drop of more than 30% from baseline; the use of medications for bradycardia intervention
Measured: from randomization to 48 hours after the end of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Air Force Medical University, First Affiliated Hospital, Sun Yat-Sen University, Zhongnan University Xiangya Second Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital of Suzhou Medical College, The First Affiliated Hospital of Nanchang University, China-Japan Union Hospital, Jilin University, Zhongnan Hospital, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Kunming Medical University, Sichuan Academy of Medical Sciences, Anhui provincial chest hospital, The Guangxi Zhuang Autonomous Region People's Hospital, Second Affiliated Hospital of Suzhou University, The Ninth People's Hospital of Suzhou, Fifth Affiliated Hospital of Xinjiang Medical University, Xuzhou Medical University Hospital, First People's Hospital of Hangzhou, Hebei Medical University Fourth Hospital, Huai'an First People's Hospital, Jinan City People's Hospital, The First People's Hospital of Lianyungang, Jiangsu Subei People's Hospital, Suqian First Hospital, Taian City Central Hospital, Xuzhou Central Hospital, The first People's Hospital of Yancheng City, The First People's Hospital of Zunyi, Jiangxi Provincial People's Hopital, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Fei Peng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538883
- Sponsor's protocol ID
- SAME study
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06538883
- Acronym / sponsor ID
- SAME study
- Conditions
- Sedation, Mechanical Ventilation
- Keywords
- Sedation, Mechanical Ventilation, ICU, Ciprofol, Propofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Air Force Medical University, First Affiliated Hospital, Sun Yat-Sen University, Zhongnan University Xiangya Second Hospital, Renmin Hospital of Wuhan University, First Affiliated Hospital of Suzhou Medical College, The First Affiliated Hospital of Nanchang University, China-Japan Union Hospital, Jilin University, Zhongnan Hospital, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Kunming Medical University, Sichuan Academy of Medical Sciences, Anhui provincial chest hospital, The Guangxi Zhuang Autonomous Region People's Hospital, Second Affiliated Hospital of Suzhou University, The Ninth People's Hospital of Suzhou, Fifth Affiliated Hospital of Xinjiang Medical University, Xuzhou Medical University Hospital, First People's Hospital of Hangzhou, Hebei Medical University Fourth Hospital, Huai'an First People's Hospital, Jinan City People's Hospital, The First People's Hospital of Lianyungang, Jiangsu Subei People's Hospital, Suqian First Hospital, Taian City Central Hospital, Xuzhou Central Hospital, The first People's Hospital of Yancheng City, The First People's Hospital of Zunyi, Jiangxi Provincial People's Hopital, Henan Provincial People's Hospital
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Sedation is a cornerstone of management for mechanically ventilated patients in the intensive care unit (ICU). Achieving early target sedation while maintaining hemodynamic stability remains a major clinical challenge. Ciprofol, a novel intravenous sedative agent structurally derived from propofol, has shown promising efficacy and a potentially improved hemodynamic profile in preclinical and phase II/III studies. However, high-quality evidence from large, multicenter randomized trials in real-world ICU settings is lacking.
Objective: To evaluate the efficacy and safety of ciprofol versus propofol for sedation in mechanically ventilated ICU patients, as assessed by the incidence of early successful sedation without hypotension.
Methods: This is a multicenter, randomized, double-blind, parallel-group, active-controlled, noninferiority clinical trial conducted across 31 centers in China. A total of 366 patients will be randomized in a 1:1 ratio to receive either ciprofol or propofol. Eligible patients are adults (aged 18-80 years) admitted to the ICU receiving mechanical ventilation, with an expected sedation duration of 6-24 hours and a target Richmond Agitation-Sedation Scale (RASS) of +1 to -2. Key exclusion criteria include known allergy to ciprofol, BMI <18 or >30 kg/m², prior sedation for >3 days, severe cardiovascular, hepatic or renal dysfunction, Glasgow Coma Scale ≤12, expected survival ≤24 hours, pregnancy or lactation, and participation in other drug trials.
Patients will receive a loading dose (ciprofol 0.1 mg/kg or propofol 0.5 mg/kg) over 4 minutes, followed by a maintenance infusion titrated to achieve the target RASS. Remifentanil will be used for analgesia throughout. The primary composite outcome is successful sedation without hypotension within 30 minutes of study drug administration, defined as: (1) RASS within the target range of +1 to -2; (2) no use of rescue sedation; and (3) no occurrence of hypotension. Hypotension is defined as systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, mean arterial pressure <70 mmHg, or a >30% drop from baseline. Secondary outcomes include sedation success without hypotension at 1 hour, sedation without circulatory depression (hypotension or bradycardia) at 1 hour, drug utilization, duration of mechanical ventilation, extubation time, awakening time, delirium incidence (CAM-ICU), ICU length of stay, 28-day mortality, and safety profiles.
Based on an assumed 92% incidence in the ciprofol group versus 82% in the propofol group, with a two-sided alpha of 0.05 and 80% power, and allowing for a 5% dropout rate, the required sample size is 183 patients per group, totaling 366 patients. Analysis will be performed on the intention-to-treat population using logistic regression for the primary outcome, with results expressed as risk difference and relative risk with 95% confidence intervals.
Ethics and Dissemination: The study protocol has been approved by the ethics committee of the coordinating center and will be submitted to all participating sites. The trial is registered with ClinicalTrials.gov (NCT06538883). Results will be disseminated through peer-reviewed publications and academic presentations.
Keywords: Ciprofol, Propofol, Intensive care unit, Mechanical ventilation, Sedation, Hypotension, Randomized controlled trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol | Experimental | Drug: Ciprofol |
| Propofol | Active comparator | Drug: Sedation with Propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolDuring the drug administration period, ciprofol were IV infused at loading doses of 0.1 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline. | Drug | Ciprofol |
| Sedation with PropofolDuring the drug administration period, propofol were IV infused at loading doses of 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Propofol were then immediately administered at an initial maintenance dose of 1.5 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline. | Drug | Propofol |
Primary outcome
The primary outcome is the rate of successful sedation without hypotension
Time frame: within the first 30 minutes of administering the study drug
The primary outcome is the rate of successful sedation without hypotension, which have to meet the following three criteria simultaneously: 1) Sedation within the RASS target (+1 to -2); 2) No rescue therapy is used; 3) No hypotension occurs, within the first 30 minutes of administering the study drug.
11 secondary outcomes
the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;
Time frame: within the first 1hour of administering the study drug
the rate of within sedation target (RASS: +1 to -2) without circulatory inhibition (defined as either hypotension or bradycardia) in the first 1hour of administering the study drug;
Time frame: within the first 1hour of administering the study drug
Usage of study drugs
Time frame: within the first 24hours of administering the study drug
Duration of mechanical ventilation
Time frame: from randomization until the date of first extubation or date of death from any cause, whichever came first, assessed up to 28 days
Extubation time
Time frame: from stopping the study drug to extubation, or death from any cause, or 28 days
Awakening time
Time frame: from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 24h after stopping the drug.
Incidence of delirium
Time frame: from administation of study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days
Length of ICU stay
Time frame: the time from randomization to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days
The 28-day mortality
Time frame: from randomization to 28 days
Incidence of hypotension
Time frame: from randomization to 48 hours after the end of study drug administration
Incidence of bradycardia
Time frame: from randomization to 48 hours after the end of study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Sedation with Propofol in people with Sedation and Mechanical Ventilation, run by Zhongda Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the rate of successful sedation without hypotension (time frame: within the first 30 minutes of administering the study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.