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Prospective Validation of the Eleveld Model of Propofol for Procedural Sedation in Adults.

University Medical Center Groningen · 2024
ClinicalTrials.gov · Datasets · License: Public Domain · 2024
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validation
The goal of this prospective observational study is to identify effect site concentrations (CET) of propofol using the Eleveld model for different levels of procedural sedation. The main question it aims to answer is to identify CET propofol using the Eleveld model for different levels of procedural sedation as measured by the modified observer's assessment of alertness and sedation score (MOAAS) and EEG monitoring. Participants vital signs will be monitored according to the departmental protocol. Sedation will be administered using Target-Controlled Infusion (TCI) of propofol (administered by effect-site TCI using the Eleveld model) and remifentanil (administered by effect site TCI using the Eleveld model). Target controlled infusion of propofol and remifentanil is according to the departmental protocol. The MOAAS score will be noted every 5 minutes or when the target effect site concentration of propofol is altered. Depth of sedation will also be monitored using a non-invasive BIS® monitor.
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