NCT01083797 - 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)

Huupponen E, Maksimow A, Lapinlampi P, Särkelä M, Saastamoinen A, Snapir A, Scheinin H, Scheinin M, Meriläinen P, Himanen SL, Jääskeläinen S
Electroencephalogram spindle activity during dexmedetomidine sedation and physiological sleep. Acta Anaesthesiol Scand. 2008 Feb;52(2):289-94. Epub 2007 Nov 14.
Lubisch N, Roskos R, Berkenbosch JW
Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol. 2009 Aug;41(2):88-94. doi: 10.1016/j.pediatrneurol.2009.02.006.

Sedation to Electroencephalography With Dexmedetomidine or Chloral Hydrate: a Comparative Study of the Qualitative and Quantitative Electroencephalogram Pattern

Details for clinical trial NCT01083797

Clinical trial NCT01083797 - References