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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ciprofol | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explore the effect of ciprofol on tidal volume | Change from baseline in tidal volume (ml) at 30 minutes after infusion of ciprofol | 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 | 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 | 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 | 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 | 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 | At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Xin Zhou, MD | Contact | +8613801183875 | zhoujx.cn@icloud.com | |
| Rui Su | Contact | +8618611993866 | surui1969@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40070647 | Derived | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000730795 | (2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol |
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Change from baseline in respiratory rate (breaths/min) at 30 minutes after infusion of ciprofol at different rates |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |