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.


METHODS
Open label, single-center studies.


METHODS
Endoscopy clinics in Charlottesville, Virginia, and Gent, Belgium.


METHODS
Twenty-four adults per center; 12 colonoscopies, 12 EGDs.


METHODS
Propofol sedation with CAPS by endoscopist/registered nurse care teams.


METHODS
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.


CONCLUSIONS
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.
Pambianco
Daniel J
DJ
Charlottesville Medical Research, Charlottesville, Virginia, USA.
Whitten
Christopher J
CJ
Moerman
Annelies
A
Struys
Michel M
MM
Martin
James F
JF
D000328:Adult; D000368:Aged; D000762:Anesthesia Recovery Period; D001530:Belgium; D003113:Colonoscopy / Q000379:methods; D016292:Procedural Sedation / Q000379:methods / Q000451:nursing*; D004305:Dose-Response Relationship, Drug; D004360:Drug Therapy, Computer-Assisted; D016099:Endoscopy, Gastrointestinal / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000517:prevention & control; D010147:Pain Measurement; D010348:Patient Care Team; D015742:Propofol; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D014481:United States
D015742:Propofol