Mechanical Ventilation, Sedation and Analgesia
Conditions
Keywords
sedation, analgesia, mechanical ventilation, respiratory patterns, respiratory drive, inspiratory effort
Brief 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. 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.
Interventions
DRUGciprofol
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.
Sponsors
Capital Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Explore the effect of ciprofol on tidal volume | 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 | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explore the effect of ciprofol on systolic blood pressure | 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) | Change from baseline in systolic blood pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on diastolic blood pressure | 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) | Change from baseline in diastolic pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on mean arterial pressure | 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) | Change from baseline in mean arterial pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on tidal volume | 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) | Change from baseline in tidal volume (ml) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on saturation of pulse oxygen | 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) | Change from baseline in saturation of pulse oxygen (%) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on end-tidal carbon dioxide pressure | 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) | Change from baseline in end-tidal carbon dioxide pressure (mmHg) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on RASS score | 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) | Change from baseline in RASS score at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on heart rate | 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) | Change from baseline in heart rate (beats/min) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on respiratory rate | 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) | Change from baseline in respiratory rate (breaths/min) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on minute ventilation | 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) | Change from baseline in minute ventilation (L/min) at 30 minutes after infusion of ciprofol at different infusion rates |
| Explore the effect of ciprofol on P0.1 | 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) | Change from baseline in P0.1 (cmH2O) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on PMI | 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) | Change from baseline in PMI (cmH2O) at 30 minutes after infusion of ciprofol at different rates |
| Explore the effect of ciprofol on ΔPocc | 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) | Change from baseline in ΔPocc (cmH2O) at 30 minutes after infusion of ciprofol at different rates |
Countries
China
Contacts
Primary ContactJian-Xin Zhou, MD
Backup ContactRui Su
Outcome results
None listed