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RECRUITING
NCT07301970

Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

DRUG

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