NCT01250418 - 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)

Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL
Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
Dressler O, Schneider G, Stockmanns G, Kochs EF
Awareness and the EEG power spectrum: analysis of frequencies. Br J Anaesth. 2004 Dec;93(6):806-9. Epub 2004 Sep 17.
Glass PS, Bloom M, Kearse L, Rosow C, Sebel P, Manberg P
Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers. Anesthesiology. 1997 Apr;86(4):836-47.
Iselin-Chaves IA, Flaishon R, Sebel PS, Howell S, Gan TJ, Sigl J, Ginsberg B, Glass PS
The effect of the interaction of propofol and alfentanil on recall, loss of consciousness, and the Bispectral Index. Anesth Analg. 1998 Oct;87(4):949-55.
Sebel PS, Lang E, Rampil IJ, White PF, Cork R, Jopling M, Smith NT, Glass PS, Manberg P
A multicenter study of bispectral electroencephalogram analysis for monitoring anesthetic effect. Anesth Analg. 1997 Apr;84(4):891-9.
Sigl JC, Chamoun NG
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Song D, Joshi GP, White PF
Titration of volatile anesthetics using bispectral index facilitates recovery after ambulatory anesthesia. Anesthesiology. 1997 Oct;87(4):842-8.
Wong CA, Fragen RJ, Fitzgerald P, McCarthy RJ
A comparison of the SNAP II and BIS XP indices during sevoflurane and nitrous oxide anaesthesia at 1 and 1.5 MAC and at awakening. Br J Anaesth. 2006 Aug;97(2):181-6. Epub 2006 May 23.

A Comparison Between the Correlation of the Bispectral Index Versus Snap Index With the Observer's Assessment of Alertness and Sedation (OAA/S) Scale During a Sedation Regimen With and Without Ketamine

Details for clinical trial NCT01250418

Clinical trial NCT01250418 - References