Compare Propofol to Fentanyl and Midazolam for Colonoscopy
|ClinicalTrials.gov Identifier: NCT01488045|
Recruitment Status : Unknown
Verified December 2014 by Saint Joseph Mercy Health System.
Recruitment status was: Active, not recruiting
First Posted : December 8, 2011
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer Rectal Cancer Colonic Diverticulosis||Drug: Fentanyl Drug: Propofol Drug: Midazolam||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||June 2016|
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
- Patient satisfaction [ Time Frame: Survey completed 30-45 minutes following colonoscopy procedure ]Measured by the patient
- Patient discomfort [ Time Frame: Survey completed immediately following colonoscopy procedure ]Measured by the endoscopist
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488045
|United States, Michigan|
|Saint Joseph Mercy Hospital|
|Ann Arbor, Michigan, United States, 48106|
|Principal Investigator:||Robert Cleary, MD||Saint Joseph Mercy Health System|