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Gastrointest Endosc. 2011 Apr;73(4):765-72. doi: 10.1016/j.gie.2010.10.031. Epub 2010 Dec 18.

Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study.

Author information

1
Charlottesville Medical Research and Charlottesville Gastroenterology Associates, 325 Winding River Lane, Suite 102, Charlottesville, VA 22911, USA.

Abstract

BACKGROUND:

The SEDASYS System is an investigational computer-assisted personalized sedation system integrating propofol delivery with patient monitoring to enable endoscopist/nurse teams to safely administer propofol.

OBJECTIVE:

To compare the safety and effectiveness of the SEDASYS System to the current standard of care for sedation during routine endoscopic procedures.

DESIGN:

Nonblinded multicenter randomized comparative study.

SETTING:

Four ambulatory surgery centers, 3 endoscopy centers, and 1 academic center in the United States.

PATIENTS:

One thousand American Society of Anesthesiologists physical status class I to III adults undergoing routine colonoscopy or EGD.

INTERVENTIONS:

Sedation with the SEDASYS System (SED) and sedation with each site's current standard of care (CSC; benzodiazepine/opioid combination).

MAIN OUTCOME MEASUREMENTS:

Area under the curve of oxygen desaturation was the primary endpoint. Secondary endpoints included patient satisfaction, clinician satisfaction, level of sedation, and patient recovery time.

RESULTS:

Four hundred ninety-six patients were randomized to SED and 504 to CSC. Area under the curve of oxygen desaturation was significantly lower for SED (23.6 s·%) than for CSC (88.0 s·%; P = .028). Patients were predominately minimally to moderately sedated in both groups. SED patients were significantly more satisfied than CSC patients (P = .007). Clinician satisfaction was greater with SED than with CSC (P < .001). SED patients recovered faster than CSC patients (P < .001). The incidence of adverse events was 5.8% in the SED group and 8.7% in the CSC group.

LIMITATIONS:

Nonblinded.

CONCLUSIONS:

The SEDASYS System could provide endoscopist/nurse teams a safe and effective on-label means to administer propofol to effect minimal to moderate sedation during routine colonoscopy and EGD.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00452426.

PMID:
21168841
DOI:
10.1016/j.gie.2010.10.031
[Indexed for MEDLINE]

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