Colon Cancer Clinical Trial

Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Summary

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

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Full Description

Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.

Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects

Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.

Other Variables of Interest.

Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
Difficulty of procedure rated by the physician on a scale of 0-10
Colonoscopy completion rates (intubation of cecum).
Complications including oxygen desaturation or hypotension.
Cost of the two medication regiments

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age > 18
Elective outpatient colonoscopy
American Society of Anesthesiology Class (ASA) < IV

Exclusion Criteria:

Age < 18
Inpatient status
Emergency procedure
History of colonic or rectal resection
History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
ASA of IV
Neurological deficit
Acute gastrointestinal bleeding
On anticoagulation agents
Noncompliance with bowel regiment
Pregnant women
Prisoners

Study is for people with:

Colon Cancer

Estimated Enrollment:

289

Study ID:

NCT01488045

Recruitment Status:

Completed

Sponsor:

Saint Joseph Mercy Health System

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There is 1 Location for this study

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Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States

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Study is for people with:

Colon Cancer

Estimated Enrollment:

289

Study ID:

NCT01488045

Recruitment Status:

Completed

Sponsor:


Saint Joseph Mercy Health System

How clear is this clinincal trial information?

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