Colonoscopy Preparation, Premedication, and Sedation
Colonoscopy Preparation, Premedication, and Sedation
Imagine a device that could calculate and deliver the appropriate loading and maintenance dose of propofol, monitor vital signs and adjust the infusion rate of propofol in response to changes in physiologic parameters and the patient's level of response. Such a device, called SEDASYS® (Ethicon Endo-Surgery, OH, USA), was actually designed to provide moderate sedation using target-controlled infusion of propofol and a proprietary closed-loop system that adjusts the infusion rate of propofol. In a prospective, randomized multicenter study comparing SEDASYS® to conventional sedation using midazolam and an opioid, subjects sedated by the propofol delivery system experienced less hypoxemia than those receiving standard sedation. A total of 1000 patients undergoing EGD or colonoscopy were randomized with roughly equal numbers of patients in each arm. The primary end point was oxygen desaturation area under the curve, which is the summed difference between the threshold oxygen saturation (defined as 90%) and the subject's oxygen saturation during the examination. The investigators observed that the hypoxemia area under the curve was significantly higher (more oxygen desaturation) for those receiving standard sedation compared to the computer-assisted propofol group (88.8 vs 23.6 s%; p = 0.028). Additionally, both patient and clinician satisfaction were significantly greater in the computer-assisted propofol group compared with standard sedation. No serious adverse events were observed in the propofol group versus three with standard sedation. The device received an 'approvable letter' from the FDA upon appeal following an initial decision of 'nonapprovable'. It will be interesting to see how this device fits in to the overall landscape of endoscopic sedation in various countries around the world.
Computer-assisted Propofol Delivery
Imagine a device that could calculate and deliver the appropriate loading and maintenance dose of propofol, monitor vital signs and adjust the infusion rate of propofol in response to changes in physiologic parameters and the patient's level of response. Such a device, called SEDASYS® (Ethicon Endo-Surgery, OH, USA), was actually designed to provide moderate sedation using target-controlled infusion of propofol and a proprietary closed-loop system that adjusts the infusion rate of propofol. In a prospective, randomized multicenter study comparing SEDASYS® to conventional sedation using midazolam and an opioid, subjects sedated by the propofol delivery system experienced less hypoxemia than those receiving standard sedation. A total of 1000 patients undergoing EGD or colonoscopy were randomized with roughly equal numbers of patients in each arm. The primary end point was oxygen desaturation area under the curve, which is the summed difference between the threshold oxygen saturation (defined as 90%) and the subject's oxygen saturation during the examination. The investigators observed that the hypoxemia area under the curve was significantly higher (more oxygen desaturation) for those receiving standard sedation compared to the computer-assisted propofol group (88.8 vs 23.6 s%; p = 0.028). Additionally, both patient and clinician satisfaction were significantly greater in the computer-assisted propofol group compared with standard sedation. No serious adverse events were observed in the propofol group versus three with standard sedation. The device received an 'approvable letter' from the FDA upon appeal following an initial decision of 'nonapprovable'. It will be interesting to see how this device fits in to the overall landscape of endoscopic sedation in various countries around the world.