Aspect Medical Systems, Inc. (Aspect) has planned to complete the EndoBISs Study for Bispectral Index Monitor by July 2010. The aim of the study is to investigate the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. The study is currently recruiting participants in Germany.
This randomized, open label, active control, parallel assignment, safety study will enroll approximately 144 participants. The study Principal Investigator is Stefan von Delius, MD Klinikum rechts der Isar der Technischen Universitat Munchen.
A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient’s electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.
The official title of the study is “Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography”.