Effect of Anesthesia on Force Application During Colonoscopy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02101099

Acronym

CFM

Enrollment

102

Registered

2014-04-01

Start date

2014-03-31

Completion date

2015-12-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Colonoscopy, Force, Monitor, Endoscopist, Conscious, Sedation, Propofol

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.

Interventions

DEVICEColonoscopy Force Monitor

Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Peak push force is increased in patients receiving propofol as compared to conscious sedation.	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026