Compare Propofol to Fentanyl and Midazolam for Colonoscopy
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.|
- Patient satisfaction [ Time Frame: Survey completed 30-45 minutes following colonoscopy procedure ] [ Designated as safety issue: No ]Measured by the patient
- Patient discomfort [ Time Frame: Survey completed immediately following colonoscopy procedure ] [ Designated as safety issue: No ]Measured by the endoscopist
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.
Other Names:Drug: Midazolam
Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.
Other Name: Versed
Active Comparator: Propofol
Propofol sedation for colonoscopy discomfort
Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.
Other Name: Diprivan
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488045
|United States, Michigan|
|Saint Joseph Mercy Hospital|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Robert Cleary, MD||Saint Joseph Mercy Health System|