Mechanical VentilationNCT06287138
The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients
A study testing ciprofol in people with Mechanical Ventilation and Sedation and Analgesia, run by Capital Medical University at 1 site in China.
Trial summary
Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Sedation and Analgesia
- What is being tested?
- ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2023to 31 Mar 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient received surgery under general anesthesia and admitted into the ICU
- The patient has been intubated and is receiving invasively mechanically ventilated with the mode of pressure support (PSV) or continuous positive airway pressure (CPAP)
- The patient requires sedative medication targeting RASS -2 to +1 for comfort, safety and to facilitate the delivery of life support measures
Who cannot join
- Age < 18 years
- Body mass index (BMI) <18 or >30 kg/m2
- Pregnancy or lactation
- Brain stem tumors, myasthenia gravis, or neuromuscular diseases
- Acute severe neurological disorder and any other condition interfering with RASS assessment
- Systolic blood pressure < 90 mmHg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors
Show all 11Show fewer
- Heart rate < 50 beats per minute or second- or third-degree heart block in the absence of a pacemaker
- Contraindicate or allergic to any of the study medications
- Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C)
- Chronic kidney disease with glomerular filtration rate (GFR) < 60 ml/min/1.73m2
- Alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071
Jian-Xin Zhou, MD, 8610 59978019, zhoujx.cn@icloud.com
Rui Su, +8618611993866, surui1969@163.com
About this study
Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients.
- Conditions
- Mechanical Ventilation, Sedation and Analgesia
- Being tested
- ciprofol
- Keywords
- sedation, analgesia, mechanical ventilation, respiratory patterns, respiratory drive, inspiratory effort
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
Ciprofol will be infused at 0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h in sequence for 30 minutes at each dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Before the trial drug administration, included patients will receive a continuous infusion of remifentanil for analgesia, starting at 0.01 μg/kg/min and adjusting infusion rate to target a Critical-care Pain Observation Tool (CPOT) score of 0-1. The experimental drug was not to be administered until it was confirmed that the patient's baseline sedation level had reached a RASS score of ≥ -2. For sedation, the ciprofol was started at the rate of 0.3 mg/kg/h and maintained for 30 minutes. Then, the initial infusion rate was increased to 0.4, 0.5, 0.6, 0.7, and up to 0.8 mg/kg/h every 30 minutes. The infusion of ciprofol would be stopped if the RASS score ≤ -4, respiratory rate < 8 breaths/min, or Saturation of pulse oxygen (SpO2) < 90% before the maximal dose of 0.8 mg/kg/h was achieved. Receives: Drug: ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the effect of ciprofol on tidal volume
Change from baseline in tidal volume (ml) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Explore the effect of ciprofol on respiratory rate
Change from baseline in respiratory rate (breaths/min) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Explore the effect of ciprofol on minute ventilation
Change from baseline in minute ventilation (L/min) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Explore the effect of ciprofol on P0.1
Change from baseline in P0.1 (cmH2O) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Explore the effect of ciprofol on PMI
Change from baseline in PMI (cmH2O) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Explore the effect of ciprofol on ΔPocc
Change from baseline in ΔPocc (cmH2O) at 30 minutes after infusion of ciprofol
Measured: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Secondary outcomes (13)
Explore the effect of ciprofol on tidal volume
Change from baseline in tidal volume (ml) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on respiratory rate
Change from baseline in respiratory rate (breaths/min) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on minute ventilation
Change from baseline in minute ventilation (L/min) at 30 minutes after infusion of ciprofol at different infusion rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on P0.1
Change from baseline in P0.1 (cmH2O) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on PMI
Change from baseline in PMI (cmH2O) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on ΔPocc
Change from baseline in ΔPocc (cmH2O) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on systolic blood pressure
Change from baseline in systolic blood pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on diastolic blood pressure
Change from baseline in diastolic pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on mean arterial pressure
Change from baseline in mean arterial pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on heart rate
Change from baseline in heart rate (beats/min) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on saturation of pulse oxygen
Change from baseline in saturation of pulse oxygen (%) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on end-tidal carbon dioxide pressure
Change from baseline in end-tidal carbon dioxide pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on RASS score
Change from baseline in RASS score at 30 minutes after infusion of ciprofol at different rates
Measured: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start10 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287138
- Sponsor's protocol ID
- KY2023-182-03
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Su R, Zhang L, Wang YM, Miao MY, Wang S, Cao Y, Zhou JX. Effects of cipepofol on breathing patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients. Front Med (Lausanne). 2025 Feb 25;12:1539238. doi: 10.3389/fmed.2025.1539238. eCollection 2025.
PubMed 40070647
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06287138
- Acronym / sponsor ID
- KY2023-182-03
- Conditions
- Mechanical Ventilation, Sedation and Analgesia
- Keywords
- sedation, analgesia, mechanical ventilation, respiratory patterns, respiratory drive, inspiratory effort
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 29 Feb 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.
Sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. Sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. The sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the Richmond Agitation Sedation Scale (RASS). However, studies have found that sedation depth based on RASS is not a reliable marker of respiratory drive during critical illness. In recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as P0.1, Pocc, Pmus, WOB, and PTP. However, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. Ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. Therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: ciprofolBefore the trial drug administration, included patients will receive a continuous infusion of remifentanil for analgesia, starting at 0.01 μg/kg/min and adjusting infusion rate to target a Critical-care Pain Observation Tool (CPOT) score of 0-1. The experimental drug was not to be administered until it was confirmed that the patient's baseline sedation level had reached a RASS score of ≥ -2. For sedation, the ciprofol was started at the rate of 0.3 mg/kg/h and maintained for 30 minutes. Then, the initial infusion rate was increased to 0.4, 0.5, 0.6, 0.7, and up to 0.8 mg/kg/h every 30 minutes. The infusion of ciprofol would be stopped if the RASS score ≤ -4, respiratory rate < 8 breaths/min, or Saturation of pulse oxygen (SpO2) < 90% before the maximal dose of 0.8 mg/kg/h was achieved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient received surgery under general anesthesia and admitted into the ICU
- The patient has been intubated and is receiving invasively mechanically ventilated with the mode of pressure support (PSV) or continuous positive airway pressure (CPAP)
- The patient requires sedative medication targeting RASS -2 to +1 for comfort, safety and to facilitate the delivery of life support measures
Key exclusion criteria (11 listed)
- Age < 18 years
- Body mass index (BMI) <18 or >30 kg/m2
- Pregnancy or lactation
- Brain stem tumors, myasthenia gravis, or neuromuscular diseases
- Acute severe neurological disorder and any other condition interfering with RASS assessment
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 |
|---|---|---|
| ciprofolCiprofol will be infused at 0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h in sequence for 30 minutes at each dose. | Drug | Experimental arm |
Primary outcome
Explore the effect of ciprofol on tidal volume
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in tidal volume (ml) at 30 minutes after infusion of ciprofol
Explore the effect of ciprofol on respiratory rate
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in respiratory rate (breaths/min) at 30 minutes after infusion of ciprofol
Explore the effect of ciprofol on minute ventilation
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in minute ventilation (L/min) at 30 minutes after infusion of ciprofol
Explore the effect of ciprofol on P0.1
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in P0.1 (cmH2O) at 30 minutes after infusion of ciprofol
Explore the effect of ciprofol on PMI
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in PMI (cmH2O) at 30 minutes after infusion of ciprofol
Explore the effect of ciprofol on ΔPocc
Time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes
Change from baseline in ΔPocc (cmH2O) at 30 minutes after infusion of ciprofol
13 secondary outcomes
Explore the effect of ciprofol on tidal volume
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on respiratory rate
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on minute ventilation
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on P0.1
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on PMI
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on ΔPocc
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on systolic blood pressure
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on diastolic blood pressure
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on mean arterial pressure
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on heart rate
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on saturation of pulse oxygen
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on end-tidal carbon dioxide pressure
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Explore the effect of ciprofol on RASS score
Time frame: At baseline (before sedation with ciprofol) and 30 minutes following each infusion rate adjustment (0.3，0.4，0.5，0.6，0.7，0.8 mg/kg/h)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 40070647Su R, Zhang L, Wang YM, Miao MY, Wang S, Cao Y, Zhou JX. Effects of cipepofol on breathing patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients. Front Med (Lausanne). 2025 Feb 25;12:1539238. doi: 10.3389/fmed.2025.1539238. eCollection 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ciprofol in people with Mechanical Ventilation and Sedation and Analgesia, run by Capital Medical University 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?
The sponsor lists 3 inclusion and 11 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (+8613801183875, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explore the effect of ciprofol on tidal volume (time frame: At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287138, which also lists 1 linked publication.
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 29 Feb 2024.