Compare Propofol to Fentanyl and Midazolam for Colonoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | June 2011 |
| End Date: | June 2016 |
| Contact: | Robert K Cleary, MD |
| Email: | clearyrk@trinity-health.org |
| Phone: | 734-712-8150 |
Randomized Trial to 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.
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.
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
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
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
We found this trial at
1
site
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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