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

Capital Medical University

Status: Enrolling

Conditions: Mechanical Ventilation; Sedation and Analgesia

Treatments: Drug: ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06287138

KY2023-182-03

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental arm

Experimental group

Description:

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.

Treatment:

Drug: ciprofol