NCT02101099

Effect of Anesthesia on Force Application During Colonoscopy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (actual)
• Sponsor: Artann Laboratories · Industry
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

Interventions

Type	Name	Description
DEVICE	Colonoscopy Force Monitor	Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-04-01
• Last updated: 2016-07-12

Locations

3 sites across 1 country: United States