Study Reveals Sedation Not Required for Endoscopy Procedures

Clinical studies conducted in the U.S. and Belgium reveal that endoscopy procedures using sedation can be performed with high physician and patient satisfaction using minimal or moderate propofol sedation. The results, which were presented on Wednesday, October 18 at the American Society of Anesthesiologists (ASA) 2006 Annual Meeting, are from stage I of studies with the first computer-assisted personalized sedation (CAPS) technology, an investigational system intended to administer propofol sedation.
The minimal and moderate sedation levels were evidenced by the Modified Observer’s Assessment of Alertness and Sedation Scale (MOAA/S), a clinical measure of depth of sedation. In these studies, 97 percent of the time subjects’ MOAA/S scores equated to minimal or moderate sedation on the ASA Continuum of Depth of Sedation. The sedation levels were achieved using a mean propofol dose of 98.2 milligrams for colonoscopy and 59.6 milligrams for upper endoscopy. None of the patients required the assistance of manual or mechanical ventilation during the procedures and no device-related adverse events were reported. The system is an investigational product limited by U.S. law to investigational use only.