Effect of Anesthesia on Force Application During Colonoscopy



Status:Completed
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:30 - 75
Updated:7/13/2016
Start Date:March 2014
End Date:December 2015

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The aim of the study is to determine if more force is used during colonoscopy when patients
receive monitored anesthesia with propofol versus conscious sedation. Force measurements
will be performed using the colonoscopy force monitor (CFM). This device measures the
magnitude and direction of force applied to the insertion tube of a standard colonoscope
during colonoscopy.

Randomized factorial design of colonoscopy with either propofol administered anesthesia or
conscious sedation. Twelve experienced endoscopists from community and academic centers will
perform colonoscopy using either propofol or conscious sedation on a group of 12 patients
for each endoscopist for a study total of 144 patients. An equal number of male and female
patients will be included in each group.

Inclusion Criteria:

- Male or female

- Age: 30-75 years

- ASA Class I or II

- All ethnic and racial groups will be included

Exclusion Criteria:

- Colonic pathology that in the opinion of the endoscopist could interfere with the
colonoscopy. Examples include: colonic stricture, poor preparation, obstructing
tumor.

- Specific pathology that would limit the extent of examination

- ASA class 3 or greater

- Pregnancy

- Monitored anesthesia using propofol for sedation.

- Vulnerable subjects. Students, nursing home residents, institutionalized patients,
and those with psychological or physical incapacity
We found this trial at
3
sites
Washington, District of Columbia 20057
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Washington,
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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