NCT06325033 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Eleveld DJ, Colin P, Absalom AR, Struys MMRF
Pharmacokinetic-pharmacodynamic model for propofol for broad application in anaesthesia and sedation. Br J Anaesth. 2018 May;120(5):942-959. doi: 10.1016/j.bja.2018.01.018. Epub 2018 Mar 12. Erratum In: Br J A
Vellinga R, Hannivoort LN, Introna M, Touw DJ, Absalom AR, Eleveld DJ, Struys MMRF
Prospective clinical validation of the Eleveld propofol pharmacokinetic-pharmacodynamic model in general anaesthesia. Br J Anaesth. 2021 Feb;126(2):386-394. doi: 10.1016/j
Xi C, Sun S, Pan C, Ji F, Cui X, Li T
Different effects of propofol and dexmedetomidine sedation on electroencephalogram patterns: Wakefulness, moderate sedation, deep sedation and recovery. PLoS One. 2018 Jun 19;13(6):e0199120. doi: 10.1371/journal.pone

Prospective Clinical Validation of the Eleveld Pharmacokinetic and Pharmacodynamic Model of Propofol for Procedural Sedation in Adults.

Clinical trial NCT06325033 - References