Remifentanil dosing and clearance in low-weight ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study enrolling adult ICU patients receiving invasive mechanical ventilation who are given remifentanil for analgosedation under a standardized clinical protocol. Researchers will collect arterial blood samples at predefined time points to measure remifentanil concentrations and construct a population pharmacokinetic (PopPK) model. Hemodynamic parameters and sedation adequacy will be recorded continuously, and a subset of patients receiving propofol as rescue sedation will have plasma propofol measured to evaluate its impact on blood pressure. The goal is to relate PK parameters to safety (hemodynamic stability) and sedation outcomes in low-body-weight critically ill patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Minhang Central Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Xiang Li — Shanghai Minhang Central Hospital
• Study coordinator: Xiang Li
• Email: xiangli0159@hotmail.com
• Phone: +86 18918169826

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.