Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients (NCT07301970) | Clinical Trial Compass
RecruitingNot Applicable
Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
China45 participantsStarted 2025-09-22
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma Concentration of Remifentanil
Timeframe: From the start of remifentanil administration, through the maintenance infusion phase, up to 2 hours after the end of infusion.