NCT02705079 - 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)

Riphaus A, Wehrmann T, Weber B et al
S3-guidelines-sedation in gastrointestinal endoscopy. Z Gastroenterol. 2008; 46:1298-330. Haensch K, Schultz A, Krauß T et al. Women need more Propofol than men during EEG- monitored total intravenous anaesthesia. Biomed Tech 2009;54: 76- 82 Wehrmann T, Grotkamp J, Stergiou N, Riphaus A et al. Electroencephalogram monitoring facilitates seation with propofol for routine ERCP: a randomized, controlled trial. Gastrointest Endosc (2002); 56: 817- 24

Values of Enhanced Monitoring by EEG Recording ( Narcotrend ) as an Adjunct to Standard Monitoring for Sedation in Endoscopic Ultrasonography

Clinical trial NCT02705079 - References