Computer-assisted personalized sedation for upper endoscopy and colonoscopy: a comparative, multicenter randomized study - 11/08/11
Reprint requests: Daniel J. Pambianco, MD, Charlottesville Medical Research and Charlottesville Gastroenterology Associates, 325 Winding River Lane, Suite 102 Charlottesville, VA 22911Résumé |
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. (ClinicalTrials.gov identifier: NCT00452426.)
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, ASA, AUCDesat, CSC, CSSI, FDA, MOAA/S, PSSI, SED
Plan
| DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: Drs Hardi, Pambianco, Pruitt, and Vargo have had consulting agreements with Ethicon Endo-Surgery. Dr Martin is an employee of Ethicon Endo-Surgery, Inc. Funding support for this study was provided by Ethicon Endo-Surgery, Cincinnati, Ohio. |
Vol 73 - N° 4
P. 765-772 - avril 2011 Retour au numéro
Article précédent
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