Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
Recruiting now
Conditions studied: Critical Illness, Pain
In brief
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.
Key facts
- Study ID
- NCT07301970
- Run by
- Fudan University
- People needed
- 45
- Starts
- 2025-09-22
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2025-12-24
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Shanghai Minhang Central Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.