NCT05992506 - 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)

Gutierrez R, Egana JI, Saez I, Reyes F, Briceno C, Venegas M, Lavado I, Penna A
Intraoperative Low Alpha Power in the Electroencephalogram Is Associated With Postoperative Subsyndromal Delirium. Front Syst Neurosci. 2019 Oct 18;13:56. doi: 10.3389/fnsys.
Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M
Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract availabl
Wong CK, van Munster BC, Hatseras A, Huis In 't Veld E, van Leeuwen BL, de Rooij SE, Pleijhuis RG
Head-to-head comparison of 14 prediction models for postoperative delirium in elderly non-ICU patients: an external validation study. BMJ Open. 2022 Apr 8;1

Electroencephalographic Biomarker to Predict the Development of Postoperative Delirium: a Protocol of an Observational Study in a Cohort of Patients From Five Centers

Details for clinical trial NCT05992506

Clinical trial NCT05992506 - References