BACKGROUND: Demand for colonoscopy and EGD procedures is increasing. Impediments to performing these examinations persist. Patients perceive these procedures as unpleasant and painful. The use of suboptimal sedatives results in inefficiency in endoscopy practices. Improving sedation methods utilizing precise control of preferred sedatives may increase patient satisfaction and practice efficiency. OBJECTIVE: Our purpose was to demonstrate the feasibility of computer-assisted personalized sedation (CAPS) for facilitating the precise administration of propofol by endoscopist/nurse teams, achieving minimal to moderate sedation in subjects undergoing routine endoscopies. DESIGN: Open label, single-center studies. SETTING: Endoscopy clinics in Charlottesville, Virginia, and Gent, Belgium. SUBJECTS: Twenty-four adults per center; 12 colonoscopies, 12 EGDs. INTERVENTIONS: Propofol sedation with CAPS by endoscopist/registered nurse care teams. MAIN OUTCOME MEASUREMENTS: Sedation level measured by modified observer's assessment of alertness/sedation (MOAA/S), recovery time measured from endoscope removal until Aldrete >/= 12, dosage of propofol, oxygen saturation, and safety assessments. RESULTS: Subjects responded to mild tactile and verbal stimuli MOAA/S = 5, 4, 3, or 2) 99% of the time. Mean propofol doses in the United States and Belgium were 65.4 and 72.1 mg, respectively. Mean recovery times were 29 and 10 seconds, respectively. Oxygen desaturation occurred in only 6% of subjects. No device-related adverse events occurred. LIMITATION: Open-label design. CONCLUSIONS: Using CAPS, the endoscopist/nurse teams precisely controlled the administration of propofol achieving minimal to moderate sedation in subjects undergoing colonoscopy and EGD procedures. Mean propofol dosage was low and post-procedure recovery times were rapid. The device performed well when operated by the endoscopist/nurse team, with no device-related adverse events.
BACKGROUND: Demand for colonoscopy and EGD procedures is increasing. Impediments to performing these examinations persist. Patients perceive these procedures as unpleasant and painful. The use of suboptimal sedatives results in inefficiency in endoscopy practices. Improving sedation methods utilizing precise control of preferred sedatives may increase patient satisfaction and practice efficiency. OBJECTIVE: Our purpose was to demonstrate the feasibility of computer-assisted personalized sedation (CAPS) for facilitating the precise administration of propofol by endoscopist/nurse teams, achieving minimal to moderate sedation in subjects undergoing routine endoscopies. DESIGN: Open label, single-center studies. SETTING: Endoscopy clinics in Charlottesville, Virginia, and Gent, Belgium. SUBJECTS: Twenty-four adults per center; 12 colonoscopies, 12 EGDs. INTERVENTIONS:Propofol sedation with CAPS by endoscopist/registered nurse care teams. MAIN OUTCOME MEASUREMENTS: Sedation level measured by modified observer's assessment of alertness/sedation (MOAA/S), recovery time measured from endoscope removal until Aldrete >/= 12, dosage of propofol, oxygen saturation, and safety assessments. RESULTS: Subjects responded to mild tactile and verbal stimuli MOAA/S = 5, 4, 3, or 2) 99% of the time. Mean propofol doses in the United States and Belgium were 65.4 and 72.1 mg, respectively. Mean recovery times were 29 and 10 seconds, respectively. Oxygen desaturation occurred in only 6% of subjects. No device-related adverse events occurred. LIMITATION: Open-label design. CONCLUSIONS: Using CAPS, the endoscopist/nurse teams precisely controlled the administration of propofol achieving minimal to moderate sedation in subjects undergoing colonoscopy and EGD procedures. Mean propofol dosage was low and post-procedure recovery times were rapid. The device performed well when operated by the endoscopist/nurse team, with no device-related adverse events.