Automating sedation to speed recovery

Some hospitals and gastroenterologists were looking for a way to improve the sedation of patients receiving screening colonoscopies and upper endoscopies while cutting out the costs associated with having an anesthesiologist present for the procedures.

Midazolam and fentanyl, common sedatives used by gastroenterologists, can lead to inadequate sedation of patients, who may take hours to recover. Propofol has fewer side effects but normally has to be administered by an anesthesiologist, which boosts costs.

Ethicon, a Johnson & Johnson subsidiary, developed a computer-assisted sedation system called Sedasys. Despite the concerns of anesthesiologists, the system was approved by the Food and Drug Administration in 2013 to deliver propofol for miminal-to-moderate sedation for colonoscopies and upper endoscopies without an anesthesiologist in the room. As a condition of approval, Ethicon agreed to require an anesthesiologist be on-call during procedures and to sell the system for use only by providers credentialed for the use of propofol for moderate sedation.

Last September, Virginia Mason Medical Center in Seattle became the first hospital to start using the Sedasys system. Since then, Rhode Island Hospital in Providence; ProMedica Toledo (Ohio) Hospital; Grace Medical Center in Lubbock, Texas; and Loma Linda (Calif.) University Medical Center have started using the system.

A Virginia Mason spokesman said the hospital decided to use the Sedasys system to shorten patient recovery, increase satisfaction, and allow patients to be better able to discuss results and instructions post-procedure. It also made good business sense. Faster discharges have allowed the hospital to increase its volume of upper endoscopies and colonoscopies from an average of six to eight a day.

Dr. Otto Lin, a Virginia Mason gastroenterologist, said the Sedasys system frees him from having to constantly monitor and adjust sedation, which can be distracting while trying to perform scoping procedures. Having the machine administer propofol is better because the patient's sedation is steady rather than going through peaks and troughs, which often occurs with the other sedatives.

During the pivotal study for Sedasys, 99% of patients sedated by the machine recovered from the procedure in only 10 minutes, compared with 75% of patients who received midazolam or fentanyl, said Paul Bruggeman, general manager of Ethicon's Sedasys business. Patients also had fewer episodes of oxygen desaturation when the system was used. Clinicians reported significantly higher satisfaction with the device compared with traditional sedatives, and patients also gave it slightly higher satisfaction ratings.

In a procedure using the Sedasys system, the physician measures an initial dose of propofol. After that, the system automatically reduces or stops infusion of propofol if a patient's blood oxygen level, heart rate, respiratory rate or other vitals indicate they're oversedated or hyperventilating. The system also adjusts sedation based on patient responsiveness, which the machine measures by repeatedly asking the patient through an earpiece to squeeze a handset. Sedasys also delivers an automatically determined amount of oxygen to a patient's nose and mouth based on the patient's oxygen saturation levels.

The machine doesn't increase sedation on its own. A doctor or nurse initiates an increase, and the machine has lockout timers and dose limits to ensure that physicians understand the full effect of a dosing decision before increasing the dose.

Dr. John Abenstein, president of the American Society of Anesthesiologists, said he sees the Sedasys system as a “safety device,” because even anesthesiologists can overlook the problem of patients hyperventilating. Still, he said it's unlikely that Sedasys and other machines will ever replace anesthesiologists, who still will be needed for more complex procedures.

The Sedasys system has been used for 3,200 Virginia Mason patients, nearly every patient who underwent a colonoscopy or upper endoscopy since the machine was installed. Lin said the hospital's anesthesiologists were supportive, noting it would have been difficult to introduce the technology without their support. Previously, the hospital's anesthesiologists generally did not participate in these procedures.

Ethicon has a goal of sedating 20,000 to 30,000 patients across the country this year. The company declined to provide projected sales figures or the device's price.