Positive clinical results show potential of real time propofol monitoring

Revolutionary real time propofol monitoring system to be launched as research instrument with leading anaesthesiologists.

Preliminary results from a recent clinical study on monitoring of propofol in surgery patients, which involved 150 surgery patients at the Queen Elizabeth Hospital, Birmingham, UK, met its primary objective showing that Sphere Medical’s real time propofol monitoring system provided accurate patient propofol plasma measurements when compared to a validated laboratory assay method.

Propofol is a short acting intravenous sedative used in many clinical procedures including surgery, intensive care sedation and ambulatory and dentistry care. Real time analysis of propofol levels has the potential to allow immediate control of dosing optimisation at the individual patient level. Such personalisation of care would be a completely new approach to propofol anaesthesia and sedation, which has previously not been possible.The propofol monitoring system will be initially launched as a research instrument for use by leading anaesthesiologists in hospitals in the US and Europe. The results from initial clinical evaluations are expected over the next 6 to 12 months. Sphere Medical plans to apply for full regulatory approval of the device as a Point of Care in-vitro diagnostic.

The results of the clinical study announced today will be presented by Dr Tom Clutton-Brock, Head of the Department of Anaesthesia and Intensive Care at The University of Birmingham Medical School at ANESTHESIOLOGY 2010, the annual meeting of the American Society of Anesthesiologists. The conference will take place from 16 - 20 October in San Diego, CA. Dr Tom Clutton-Brock is on the Medical Advisory Board for Sphere Medical.