Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
Population Pharmacokinetics of Remifentanil for Analgesia and Sedation in Low-Weight Critically Ill Patients Receiving Mechanical Ventilation
Fudan University
45 participants
Sep 22, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this prospective clinical study is to learn about the population pharmacokinetics (PopPK), safety, and efficacy of remifentanil in low-body-weight patients in the Intensive Care Unit (ICU) who require mechanical ventilation. The main questions it aims to answer are: 1. What are the pharmacokinetic characteristics of remifentanil in low-weight ICU patients? 2. How does remifentanil (and concurrent propofol use) affect hemodynamic stability (such as blood pressure) and sedation efficacy in this population? Participants receiving mechanical ventilation will receive remifentanil for analgesia and sedation according to a standardized protocol. They will undergo arterial blood sampling at specific time points to measure drug concentrations. Researchers will also record hemodynamic parameters. Additionally, a subset of patients receiving propofol as a rescue sedative will have plasma propofol concentrations measured to evaluate its influence on blood pressure changes.
Eligibility
Inclusion Criteria5
- Age: ≥18 years old, regardless of sex;
- Normal weight: 18.5 kg/m² ≤ Body Mass Index (BMI) < 24 kg/m² or Low weight: BMI < 18.5 kg/m²;
- Admitted to the intensive care unit (ICU);
- Required invasive mechanical ventilation for more than 10 hours;
- The subject or their legal guardian has fully understood the potential risks and benefits of participating in this study and has signed the informed consent form.
Exclusion Criteria4
- Pregnant women;
- Presence of severe respiratory impairment or respiratory depression during the screening period;
- Known hypersensitivity to remifentanil or any of the excipients;
- Meeting other contraindications for opioid use
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients receive remifentanil for analgesia and sedation during mechanical ventilation. The administration follows standard ICU clinical practice, typically initiated at a continuous infusion rate (e.g., approximately 0.18 mg/h or weight-based equivalent) and titrated based on patient response.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07301970