NCT07301970 Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
| NCT ID | NCT07301970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 45 participants in total. It began in 2025-09-22 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Xiang Li
PRINCIPAL INVESTIGATOR
Shanghai Minhang Central Hospital
Frequently Asked Questions
Who can join the NCT07301970 clinical trial?
This trial is open to participants of all sexes, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07301970 currently recruiting?
Yes, NCT07301970 is actively recruiting participants. Contact the research team at xiangli0159@hotmail.com for enrollment information.
Where is the NCT07301970 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07301970 clinical trial?
NCT07301970 is sponsored by Fudan University. The principal investigator is Xiang Li at Shanghai Minhang Central Hospital. The trial plans to enroll 45 participants.