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

NCT ID: NCT06287138

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-10
• Study Completion Date: 2025-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

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.

Group Type: EXPERIMENTAL

ciprofol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian-Xin Zhou, MD

Role: CONTACT

Phone: +8613801183875

Email: zhoujx.cn@icloud.com

Rui Su

Role: CONTACT

Phone: +8618611993866

Email: surui1969@163.com

Facility Contacts

Jian-Xin Zhou, MD

Role: primary

Rui Su

Role: backup

References

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.

Reference Type: DERIVED

PMID: 40070647 (View on PubMed)

Other Identifiers

KY2023-182-03

Identifier Type: -

Identifier Source: org_study_id