Clinical trial NCT02101099: Effect of Anesthesia on Force Application During Colonoscopy
Official title: Effect of Anesthesia on Force Application During Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases
Keywords: Colonoscopy
Force
Monitor
Endoscopist
Conscious
Sedation
Propofol
Lead sponsor: Artann Laboratories
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Capital Digestive Care, LLC
name: University of Pennsylvania
name: Georgetown University
First posted: 2014-04-01
Enrollment: 102
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult male and female patients between the ages of 30 and 75 presenting to the participating sites for screening or diagnostic colonoscopy to be performed by any of the investigators will be considered for inclusion.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak push force is increased in patients receiving propofol as compared to conscious sedation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center, Gastroenterology
state: District of Columbia
city: Chevy Chase
country: United States
facility: Chevy Chase Endoscopy Center
state: Maryland
city: Philadelphia
country: United States
facility: Univeristy of Pennsylvania Medical Center
state: Pennsylvania
Study officials:
affiliation: Capital Digestive Care, LLC
name: Louis Y Korman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: