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Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
Sponsor: Fudan University
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.
Official title: Population Pharmacokinetics of Remifentanil for Analgesia and Sedation in Low-Weight Critically Ill Patients Receiving Mechanical Ventilation
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
45
Start Date
2025-09-22
Completion Date
2026-11-30
Last Updated
2025-12-24
Healthy Volunteers
No
Conditions
Interventions
Remifentanil
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)
Shanghai Minhang Central Hospital
Shanghai, China