Pivotal Study Shows Physician/Nurse Teams Using SEDASYS(TM) System Reduced Risk Of Over Sedation With Propofol

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 20 May 2008 - 0:00 PDT

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DDW 2008 Annual Meeting -- Ethicon Endo-Surgery announced that the results from its pivotal trial demonstrated physician/nurse teams using the SEDASYS(TM) 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 -- which will be presented Tuesday at Digestive Disease Week(i) -- included 1,000 subjects who underwent sedation for colonoscopy and EGD at eight sites and compared the SEDASYS(TM) 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(TM) 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(TM) 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(TM) 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(TM) System.

SEDASYS(TM) 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(TM) System patient responses were a MOAA/S score of 2 -- 5, indicating minimal to moderate sedation.

Minimal to moderate propofol sedation with the SEDASYS(TM) System provided patients a faster recovery from sedation than current standard of care. Patients recovered from sedation almost two times faster with the SEDASYS(TM) System and approximately 99 percent of SEDASYS(TM) System patients recovered within 10 minutes. Patient recovery time was measured from scope removal to the time the patient returned to a MOAA/S=5.

Colonoscopy is considered the gold standard for detecting colorectal cancer, the second-leading cause of cancer-related deaths in the United States. The American Cancer Society is calling for increased colorectal cancer screening and recommends that people aged 50 and older receive regular screenings.(ii)

"Patients understand that recovery from sedation takes time after a colonoscopy, but with propofol, they recuperate quicker and are functional sooner," said Dr. Pambianco. "GIs have been performing procedures with current standard of care sedatives for years and maintaining a constant sedation level in patients can be daunting. The novelty of this system is that it has the potential to accurately tune into my patient's sedation needs by following their vital signs and delivering propofol in a precise manner."

The study determined that clinicians were significantly more satisfied with the level of sedation achieved with the SEDASYS(TM) System than with current standard of care. Clinicians evaluated sedation administration using the Clinician Satisfaction with Sedation Instrument (CSSI). Additionally, patients sedated with the SEDASYS(TM) System were more satisfied with the sedation they received. Patients evaluated sedation using the Patient Satisfaction with Sedation Instrument (PSSI).

About the SEDASYS(TM) System

The SEDASYS(TM) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal to moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(TM) System enables physician/nurse teams to deliver personalized sedation. The device continuously monitors and records six patient parameters including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness. It automatically detects and responds to signs of over sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.

About Ethicon Endo Surgery

Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at http://www.ethiconendo.com.

About DDW

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org.

(C)2008 Ethicon Endo Surgery

SEDASYS is a trademark of Ethicon Endo-Surgery

DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.

Consultant to Ethicon Endo-Surgery following completion of pivotal trial.

References

(i) DDW Abstract # 682d

(ii) American Cancer Society Guidelines for the Early Detection of Cancer, http://www.cancer.org/docroot/ped/content/ped_2_3x_acs_cancer_detection_guidel ines_36.asp

Ethicon Endo Surgery
http://www.ethiconendo.com