Actively Recruiting
Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
Led by Fudan University · Updated on 2025-12-24
45
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, regardless of sex
- Normal weight defined as BMI between 18.5 kg/m2 and less than 24 kg/m2 or low weight defined as BMI less than 18.5 kg/m2
- Admitted to the intensive care unit (ICU)
- Requires invasive mechanical ventilation for more than 10 hours
- Has signed informed consent after understanding the study risks and benefits
You will not qualify if you...
- Pregnant women
- Severe respiratory impairment or respiratory depression during screening
- Known allergy to remifentanil or its ingredients
- Any other contraindications for opioid use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Minhang Central Hospital
Shanghai, China
Actively Recruiting
Research Team
X
Xiang Li
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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