Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Completed · Phase 3
Conditions studied: Colonoscopy, Endoscopy, Digestive System, Conscious Sedation
In brief
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.
Key facts
- Study ID
- NCT00452426
- Run by
- Ethicon Endo-Surgery
- People needed
- 1000
- Starts
- 2007-03-01
- Expected to finish
- 2007-10-01
- Last updated by the study team
- 2011-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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.
Where it is running
- Metropolitan Gastroenterology Group, PC — Washington D.C., District of Columbia, United States
- Fayetteville Gastroenterology Associates, PA — Fayetteville, North Carolina, United States
- Digestive Health Specialists, PA — Winston-Salem, North Carolina, United States
- The Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Nashville Medical Research Institute — Nashville, Tennessee, United States
- Charlottesville Medical Research — Charlottesville, Virginia, United States
- Digestive Health Specialists — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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