CompletedPhase 3

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

United States1,000 participantsStarted 2007-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Criteria: * Allergy or inability to tolerate study medications or components of study medications * Investigator anticipates greater than 45 minute procedure time due to known anatomical difficulty * 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.

What they're measuring

Area Under the Curve for Oxygen Desaturation (AUCDesat)

Timeframe: From administration of initial drug dose until subject recovered from effects of sedation

Trial details

NCT IDNCT00452426

SponsorEthicon Endo-Surgery

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-10

Results submitted2010-10-06