A Comparative Study of Eleveld and Schnider Pharmacokinetic Models for Target-Controlled Infusion of Propofol in Sedation of Mechanically Ventilated ICU Patients

Hacettepe University

Status: Enrolling

Conditions: Intensive Care Unit Sedation; Target Controlled Infusion of Propofol; Sedation

Treatments: Drug: propofol; Device: TCI Propofol Injection

Study type: Observational

Funder types: Other

Identifiers

NCT07239687

2024/15-02 (KA-24022)

Details and patient eligibility

About

This prospective observational study aims to compare the clinical performance of two target-controlled infusion (TCI) models, Eleveld and Schnider, for propofol sedation in mechanically ventilated intensive care unit (ICU) patients. The study evaluates sedation depth, hemodynamic stability, and recovery profiles using the Bispectral Index (BIS) and Riker Sedation-Agitation Scale. Secondary outcomes include awakening time, total propofol dose, and incidence of delirium after sedation withdrawal. The findings may help identify the most reliable pharmacokinetic model for safe and effective ICU sedation.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Age over 18 years,

Classified as ASA (American Society of Anesthesiologists physical status) class I-IV,

Being monitored in the Anesthesiology and Reanimation Intensive Care Unit of Hacettepe University Faculty of Medicine Hospital,

Availability of necessary data (medical history, laboratory results, etc.) for analysis,

Hemodynamic stability -

Exclusion Criteria:Patients who refused to participate in the study or did not provide legal consent,

Patients with an ASA (American Society of Anesthesiologists physical status) classification greater than IV,

Transition to an alternative sedation method during the study,

Contraindication to propofol infusion (e.g., propofol anaphylaxis, lipid metabolism disorders),

Patients whose sedation level could not be clinically assessed due to neurological or neurodegenerative diseases,

Patients expected to require sedation for more than 72 hours (to reduce the risk of propofol infusion syndrome)

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Trial design

84 participants in 2 patient groups

Eleveld Model Group

Description:

Patients sedated with propofol using the Eleveld pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation will be titrated to maintain a Riker Sedation-Agitation Scale score between 3 and 4 and a Bispectral Index (BIS) value of 60-80. Hemodynamic variables, awakening time, and total propofol dose will be recorded for comparison with the Schnider group.

Treatment:

Device: TCI Propofol Injection

Drug: propofol

Schnider Model Group

Description:

Patients sedated with propofol using the Schnider pharmacokinetic model via a target-controlled infusion (TCI) system. Sedation depth and hemodynamic parameters will be monitored using the same protocol as in the Eleveld group. BIS values, Riker scores, and recovery profiles will be compared to assess pharmacodynamic and clinical performance between models.

Treatment:

Device: TCI Propofol Injection

Drug: propofol