A computer-assisted personalized sedation device that delivers propofol during routine endoscopic procedures is getting a thumbs up from practitioners, according to an early clinical report.
This is among first news on the use of the computer-assisted sedation system in clinical practice in the United States.
“The administration of propofol sedation for GI endoscopy has been fraught with widespread controversy, primarily around reimbursement and privileging for its use,” said Otto Lin, MD, from the Virginia Mason Medical Center in Seattle, during a news conference here at Digestive Disease Week 2015.
This system is exciting, said Kenneth McQuaid, MD, from the VA Medical Center in San Francisco, who is secretary of the American Society of Gastrointestinal Endoscopy, and who rated this study as one of the best of the meeting.
Propofol sedation requires that an anesthesiologist be present during the procedure. However, with the SEDASYS system from Johnson & Johnson, sedation can be administered by a nonanesthesia professional.
The SEDASYS system is approved by the US Food and Drug Administration for the sedation of patients undergoing routine upper endoscopy and colonoscopy who are healthy or have only mild systemic disease.
In their study, Dr Lin and his team assessed the use of the computer-assisted sedation system in patients who underwent endoscopy from September 2014 to April 2015.
The procedures were performed by physicians and nurses specifically trained in the use of the sedation system. Of the 1466 patients, 1013 underwent colonoscopy, 285 underwent upper endoscopy, and 168 underwent upper endoscopy and colonoscopy.
Three minutes before the initiation of propofol infusion, all patients received intravenous fentanyl 50 to 100 µg. They then received a propofol loading dose, subsequent infusion, and as-needed bolus dosing.
The control group consisted of 264 patients who underwent endoscopy performed by the same group of endoscopists during the same time period but who received midazolam and fentanyl.
Greater Clinician Satisfaction
Physician satisfaction was assessed with the Clinician Satisfaction with Sedation Instrument (CSSI), and all scores were better in the propofol group than in the control group.
Physician-rated overall satisfaction was much higher because clinicians “believe that the propofol system provided a better level of sedation than other methods,” Dr Lin reported.
Patient satisfaction was assessed with the Patient Satisfaction With Sedation Instrument (PSSI). Overall satisfaction was similar in the propofol and control groups, but on other items, scores were better in the propofol group.
Table. Physician- and Patient-Rated Outcomes
|Outcome||Propofol Group||Control Group||P Value|
|Speed of sedation||1.79||2.08||.016|
|Patient postprocedure retention||1.35||2.62||.001|
|Overall satisfaction with sedation||1.63||2.08||.001|
Procedure recovery time was shorter in the propofol than in the control group (27 vs 33 minutes). Although a 6-minute difference seems minimal, it is not a true reflection of the recovery time advantage with the computer-assisted system, he explained.
Recovery time in the study was measured from arrival in the recovery unit to departure from the unit; this is often prolonged by logistic delays, such as the arrival of a family member, he pointed out.
Dr Lin said he believes that with greater efficiency on the unit, the propofol patients, who are more alert, will be discharged much sooner.
Adverse events included nine cases of laryngospasm that were managed with mask ventilation, and some cases of agitation or discomfort, which largely reflected monitoring issues.
The off-label use of the propofol system — such as for endoscopic dilation, complex polypectomy, and uncomplicated endoscopic ultrasound — appears to be safe, the researchers report. However, more experience with these procedures is warranted before it can be endorsed for these indications.
“It offers us an opportunity to deliver propofol in a manner that appears safe, effective, and hopefully cost-effective to our lower-risk patients,” Dr McQuaid told Medscape Medical News. “And it gives patients the option of a shorter recovery time,” he said.
“For several years now, even though we knew physicians and nurses could administer propofol sedation quite safely in endoscopy units,” an anesthesiologist was required “for patients who would not otherwise need an anesthesiologist,” he explained.
This system allows “our anesthesiology colleagues to be involved more with our sicker patients,” he pointed out.