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Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients

Recruitingn/aAges any - anyAllFudan University
NCT07301970 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 pla

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📋 Eligibility rules (as published)
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
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What it tests

  • Remifentanil
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Where

1 site
Shanghai Minhang Central Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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