Can a computerized system that monitors patient responsiveness and oxygen levels provide safe sedation using propofol during colonoscopy without a trained anesthetist present?
While not making a recommendation, C3 brought both its positive impressions and its concerns to consideration of a computer-assisted personalized sedation system for endoscopy procedures to the Food and Drug Administration’s Anesthesiology and Respiratory Therapy Devices Panel (ARTDP) on May 28.
C3 President Carlea Bauman testified during the ARTD Panel hearing considering approval of the Sedasys® Computer-Assisted Personalized Sedation System (CAPS). (Read her full testimony.)
Bauman pointed out that as patient advocates, C3′s first concern was for patient safety.
People undergoing screening colonoscopy are trying to prevent disease; therefore, we must minimize the risk of colonoscopy. Our overriding concern is that people undergoing screening colonoscopy are safe and comfortable.
The Sedasys CAPS automatically measures and administers propofol, a sedative. It monitors patient responsiveness, oxygen use, and breathing and adjusts dosage to maintain mild to moderate sedation during endoscopy. It is designed to be used by physician-nurse teams without the presence of an anesthesiologist.
Currently the administration of propofol is limited by its FDA approved label to “persons trained in the administration of general anesthesia and not involved in the surgical/diagnostic procedure.”
After reviewing results of a study of 1,000 endoscopy patients who randomly received propofol using the Sedasys system or standard sedation (midazolam and an opiate), C3 prepared comments for the FDA Anesthesiology and Respiratory Therapy Devices Panel.
The C3 review saw some potential positive benefits for patients with CAPS support including,
- Monitoring of patients during colonoscopy using automated response in a way that is not now routine.
- Providing propofol by continuous infusion during the procedure rather than bolus injection at the beginning.
- Providing safeguards during the procedure that reduce risk for deep sedation including restricting the loading dose of propofol and administering oxygen throughout the examination.
On the other hand, C3 had concerns which we asked the Panel to take into consideration:
- The control arm for the trial was not administration of propofol by an anesthesiologist, and — while it would have been difficult or impossible to blind the trial — C3 was concerned about possible bias.
- The primary endpoint for the trial was area of the curve measure of oxygen desaturation. Has this endpoint been validated?
- The trial excluded patients at higher risk for problems during sedation. Will the FDA approved label also exclude them and are there other patients who should not be given sedation using Sedasys?
- Only 50 patients over 70 were included in the trial. Should there be an upper age limit for Sedasys use?
- Most important: what will be the real-life, high volume experience in the community if the system is approved? What safeguards will the FDA and Sedasys manufacturers put into place during the launch and early use of the system?