GI Journal Explores Computer-Assisted Propofol System

CINCINNATI — Results from a feasibility study on computer-assisted personalized sedation (CAPS) were published in the September issue of Gastrointestinal Endoscopy. The article is titled “An assessment of computer-assisted personalized sedation: a sedation delivery system to administer propofol for gastrointestinal endoscopy,” and examined a new category of sedation that integrates drug delivery and patient monitoring to deliver personalized sedation.

The CAPS system evaluated in the study is called the SEDASYS® System, which is an investigational device currently in review with the FDA, according to Ethicon Endo-Surgery, which makes the system.  

The study involved 48 patients who underwent a colonoscopy or esophagogastroduodenoscopy (EGD). According to an Ethicon Endo-Surgery press release, the study demonstrated that this system enabled “precise and personalized delivery of propofol” at minimal tomoderate sedation levels  by non-anesthesia physician/nurse teams.

All procedures were successful and the clinicians and patients were “highly satisfied” with the outcomes, the press release continued. No device-related adverse events were reported.

“On average, patients recovered from sedation in just 19 seconds, and this rapid patient recovery may have contributed to the high satisfaction scores,” said Daniel Pambianco, MD, FACG., medical director of clinical research at Charlottesville Medical Research and principal investigator for the study. Recovery was determined based on the Aldrete score, a common measure of patient readiness for discharge.

“In many practice settings, gastroenterologists do not have broad access to anesthesiologists,” added Dr. Pambianco. “This technology could facilitate access to propofol, a sedative that many GIs find highly desirable.”

In March, Ethicon Endo-Surgery submitted a PreMarket Approval (PMA) application to the FDA for approval of the SEDASYS® System, which included the results of a 1,000 patient pivotal trial. Pending favorable FDA review, the SEDASYS® System will be the first CAPS system available to physician/nurse teams for the administration of propofol during colonoscopies and EGDs.