Population Pharmacokinetics of Remifentanil in Low-Weight Critically Ill Patients
NCT ID: NCT07301970
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
45 participants
OBSERVATIONAL
2025-09-22
2026-11-30
Brief Summary
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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.
Detailed Description
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2. Study Protocol \& Dosing Strategy: This is a single-center, prospective observational study designed to reflect real-world clinical practice. Eligible patients requiring invasive mechanical ventilation will receive remifentanil for analgesia and sedation.
* Co-administration: In accordance with standard ICU practice, remifentanil is often administered concurrently with propofol to ensure adequate sedation and analgesia.
* Dosing Regimen: The administration of a loading dose is discretionary based on the patient's clinical condition; in many cases, a continuous infusion is initiated directly without a loading dose to maintain hemodynamic stability.
* Infusion Rate: The continuous infusion is typically initiated at a standardized clinical rate (e.g., approximately 0.18 mg/h) or a weight-based equivalent.
* Titration: Subsequent dosing is titrated dynamically based on clinical response (e.g., patient comfort, ventilator synchrony) and hemodynamic tolerance.
3. Pharmacokinetic Sampling (Sparse \& Opportunistic): Blood samples are not collected at rigid clock times but are distributed to capture key PK phases:
* Absorption/Distribution Phase: Samples collected within the first hour of infusion (e.g., 1-2 samples).
* Steady State: Samples collected during stable continuous infusion.
* Elimination Phase: Samples collected immediately prior to stopping the infusion and at multiple intervals after discontinuation.
5.Hemodynamic Assessment \& Propofol Co-variate Analysis: Hemodynamic parameters (MAP, HR) are continuously monitored. Given that propofol is co-administered in most patients and significantly impacts hemodynamics, plasma propofol concentrations will be measured in a subset of patients. These data will be incorporated into the PopPK/PD analysis as a covariate to distinguish the hemodynamic effects of remifentanil from those of propofol.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Low-weight group
BMI \< 18.5
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.
Normal-weight group
18.5 ≤ BMI\< 24
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiang Li
Director
Principal Investigators
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Xiang Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai Minhang Central Hospital
Locations
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Shanghai Minhang Central Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Xiang Li
Role: primary
Other Identifiers
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2025-007-01K
Identifier Type: -
Identifier Source: org_study_id