Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
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
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Measured by the patient
Survey completed 30-45 minutes following colonoscopy procedure
Robert Cleary, MD
Saint Joseph Mercy Health System
United States: Institutional Review Board
|Saint Joseph Mercy Hospital||Ann Arbor, Michigan 48106|