Clinical trial Recruiting at 1 site Observational

Remifentanil dosing and clearance in low-weight ICU patients

Official title: Population Pharmacokinetics of Remifentanil for Analgesia and Sedation in Low-Weight Critically Ill Patients Receiving Mechanical Ventilation

Run by Fudan University · NCT07301970 · Data updated 2026-11-12

This study will test how remifentanil is processed in the body and how it affects blood pressure and sedation in low-body-weight adults on mechanical ventilation in the ICU.

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Quick facts

Study typeObservational
SexAll
Enrollment45 (estimated)
SponsorFudan University
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedSeptember 22, 2025
Main results expectedJune 30, 2026
Study endsNovember 30, 2026
Registry record updatedDecember 24, 2025
Trial IDNCT07301970 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with low or normal BMI who are admitted to the ICU, require invasive mechanical ventilation for more than 10 hours, and (or whose legal guardian) can provide informed consent are the intended participants.

Probably not a fit

Pregnant patients, those with severe respiratory depression during screening, known hypersensitivity to remifentanil, or other contraindications to opioid use are excluded and unlikely to receive direct benefit from participation.

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

Potential benefit: If successful, the results could help clinicians dose remifentanil more safely and effectively for low-weight ICU patients, potentially reducing blood-pressure-related complications and improving sedation control.

How similar studies have gone: Remifentanil's pharmacokinetics and clinical effects are well documented in surgical and general ICU populations, but dedicated population PK studies focused specifically on low-weight critically ill adults are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.