MedTrace Logo

Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients

NCT07301970 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Pain

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xiang Li · Shanghai Minhang Central Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-06-30
Completion
2026-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301970 on ClinicalTrials.gov