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Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy

2014-07-23 21:29:53 | BioPortfolio

Summary

Patients routinely receive sedation during a colonoscopy or upper endoscopy (esophagogastroduodenoscopy; EGD) procedure. Propofol is a sedative that can be used during these procedures. The purpose of this study is to determine if this CAPS device enables a physician/registered nurse (RN) team to safely and effectively administer propofol sedation during colonoscopy or EGD procedures relative to current sedation practices.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Conditions

Colonoscopy

Intervention

Computer-Assisted Personalized Sedation (CAPS) Device (SEDASYS® System), benzodiazepines and opioid sedation

Location

Metropolitan Gastroenterology Group, PC
Washington
District of Columbia
United States
20006

Status

Completed

Source

Ethicon Endo-Surgery

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:29:53-0400

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