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

NCT06287138 | Unknown DMC

• 1 other identifier: KY2023-182-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Sedation and Analgesia

Keywords

sedation; analgesia; mechanical ventilation; respiratory patterns; respiratory drive; inspiratory effort

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (13)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

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.

Drug: ciprofol

Interventions

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.

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40070647 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

+8613801183875; zhoujx.cn@icloud.com

Rui Su

CONTACT

+8618611993866; surui1969@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 29, 2024
• Study Start: May 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: February 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)