NCT00391963 - 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)

Schmidt GN, Bischoff P, Standl T, Hellstern A, Teuber O, Schulte Esch J
Comparative evaluation of the Datex-Ohmeda S/5 Entropy Module and the Bispectral Index monitor during propofol-remifentanil anesthesia. Anesthesiology. 2004 Dec;101(6):1283-90.
Vanluchene AL, Vereecke H, Thas O, Mortier EP, Shafer SL, Struys MM
Spectral entropy as an electroencephalographic measure of anesthetic drug effect: a comparison with bispectral index and processed midlatency auditory evoked response. Anesthesiology. 2004 Jul;101(1):34-42.

Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Clinical trial NCT00391963 - References