The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients

Mechanical Ventilation Clinical Trial

Official title:

The Effect of Ciprofol on Breathing Patterns, Respiratory Drive, and Inspiratory Effort in Mechanically Ventilated Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287138
• Other study ID #: KY2023-182-03
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: December 2023
• Source: Capital Medical University
• Contact: Jian-Xin Zhou, MD
• Phone: +8613801183875
• Email: zhoujx.cn[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Respiratory Aspiration
• Sedation and Analgesia

Intervention

Drug:
• ciprofol
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Explore the effect of ciprofol on ?Pocc	Change from baseline in ?Pocc (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
Secondary	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)
Secondary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Explore the effect of ciprofol on ?Pocc	Change from baseline in ?Pocc (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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)