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

Last updated: December 30, 2010
Sponsor: Ethicon Endo-Surgery
Overall Status: Completed

Phase

3

Condition

Colon Cancer Screening

Anesthesia

Treatment

N/A

Clinical Study ID

NCT00452426
CI-06-0004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years old

  • Able to comprehend, sign, and date the written informed consent form

  • English as primary language

  • Undergoing a non-emergent EGD or colonoscopy

  • Have taken nothing by mouth for a minimum of 6 hours prior to the study procedure

  • American Society of Anesthesiologists (ASA) Class I, II or III

Exclusion

Exclusion Criteria:

  • Allergy or inability to tolerate study medications or components of study medications

  • Investigator anticipates greater than 45 minute procedure time due to known anatomicaldifficulty

  • Currently using a fentanyl patch

  • History of diagnosed sleep apnea

  • History of diagnosed gastroparesis

  • Baseline oxygen saturation < 90% (room air)

  • Pregnant or nursing females

  • Body mass index (BMI) ≥ 35

  • Participation in a clinical trial within the past 30 days.

Study Design

Total Participants: 1000
Study Start date:
March 01, 2007
Estimated Completion Date:
October 31, 2007

Connect with a study center

  • Metropolitan Gastroenterology Group, PC

    Washington, District of Columbia 20006
    United States

    Site Not Available

  • Fayetteville Gastroenterology Associates, PA

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Nashville Medical Research Institute

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • Charlottesville Medical Research

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • Digestive Health Specialists

    Tacoma, Washington 98405
    United States

    Site Not Available

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