Critical Care Minutes

FDA’s anesthesiology and respiratory therapy devices advisory committee will meet May 28 in Gaithersburg, Md., to discuss Johnson & Johnson/Ethicon Endo-Surgery’s pre-market approval application for its Sedasys computer-assisted personalized sedation system, indicated for minimal to moderate sedation in adult patients undergoing colonoscopy and esophagogastroduodenoscopy procedures.

This is certainly going to spark some fireworks on both sides of the court. Can this really replace anesthesiologist presence in the GI suite? Lets see what the FDA has to say. In my opinion, we should certainly not jump to quick legislation and really put patient safety at the forefront! Just because it can be done DOESN’T mean it should be done.

Here is information about this controversial and potentially game changing technolology from JnJ.

Ethicon Endo-Surgery announced that the results from its pivotal trial demonstrated physician/nurse teams using the SEDASYS™ System reduced the risk of over sedation with propofol in patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract (EGD). The study [...] included 1,000 subjects who underwent sedation for colonoscopy and EGD at eight sites and compared the SEDASYS™ System to the current standard of care for sedation (midazolam plus fentanyl or meperidine). Results were included in Ethicon Endo-Surgery’s PreMarket Application (PMA) for approval of the SEDASYS™ System, which is currently in review with the U.S. Food and Drug Administration.

“During the trial, the system made it possible for gastroenterologists to maintain minimal to moderate sedation with propofol, and helped prevent patients from entering deep sedation, which is traditionally associated with propofol,” said Daniel Pambianco, MD, F.A.C.G., medical director of Charlottesville (Va.) Medical Research and trial investigator. “The system offers a way to personalize the level of sedation appropriate for each patient because it combines propofol delivery with sophisticated monitoring to help us better control and predict the patient’s sedation level.”

Patients who received sedation with the SEDASYS™ System experienced fewer and less significant oxygen desaturation events, a clinical sign of over sedation, than patients sedated with current standard of care. The trial demonstrated this by achieving its primary endpoint of Area Under the Curve (AUC) of oxygen desaturation (SpO2 < 90%). AUC is an objective measure of a patient’s respiratory status that incorporates incidence, duration and depth of oxygen desaturation. Patients in the SEDASYS™ System group had an average AUC value of one-third less than the current standard of care patients. No device-related adverse events occurred in patients sedated with the SEDASYS™ System.

SEDASYS™ System patients were minimally-to-moderately sedated with propofol during the study. Sedation level was assessed every two minutes using a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scale of 0-5. Patients who are minimally sedated respond readily when called by name (MOAA/S=5), while moderately sedated patients may require mild tactile stimulus to respond (MOAA/S=2-4). More than 99 percent of SEDASYS™ System patient responses were a MOAA/S score of 2 – 5, indicating minimal to moderate sedation.

(excerpt from may 2008 taken from)
Johnson and Johnson
http://www.jnj.com