An assessment of computer-assisted personalized sedation: a sedation delivery system to administer propofol for gastrointestinal endoscopy

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.

Abbreviations: ASA, American Society of Anesthesiologists, CAPS, computer-assisted personalized sedation, CSSI, clinician satisfaction with sedation instrument, MOAA/S, modified observer's assessment of alertness/sedation, NIBP, noninvasive blood pressure, PSSI, patient satisfaction with sedation instrument