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

February 27, 2024 updated by: Jian-Xin Zhou, Capital Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Explore the effect of ciprofol on tidal volume
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
At baseline (before sedation with ciprofol) and 0.3 mg/kg/h ciprofol continuous infusion for 30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Explore the effect of ciprofol on tidal volume
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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 ΔPocc
Time Frame: 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
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 systolic blood pressure
Time Frame: 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
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)
Explore the effect of ciprofol on diastolic blood pressure
Time Frame: 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
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)
Explore the effect of ciprofol on mean arterial pressure
Time Frame: 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
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)
Explore the effect of ciprofol on heart rate
Time Frame: 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
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)
Explore the effect of ciprofol on saturation of pulse oxygen
Time Frame: 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
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)
Explore the effect of ciprofol on end-tidal carbon dioxide pressure
Time Frame: 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
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)
Explore the effect of ciprofol on RASS score
Time Frame: 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
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2023-182-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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