Status:
COMPLETED
Safety and Effectiveness of a Computer-Assisted Personalized Sedation (CAPS) Device for Propofol Delivery During Endoscopy
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Colonoscopy
Endoscopy, Digestive System
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00452426
Start Date
March 1 2007
End Date
October 1 2007
Last Update
January 25 2011
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, United States, 20006
2
Fayetteville Gastroenterology Associates, PA
Fayetteville, North Carolina, United States, 28304
3
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
4
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195