Compare Propofol to Fentanyl and Midazolam for Colonoscopy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colon Cancer Rectal Cancer Colonic Diverticulosis |
Drug: Fentanyl Drug: Propofol Drug: Midazolam |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 290 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
|
Drug: Fentanyl
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
|
Drug: Propofol
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
|
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Robert K Cleary, MD | 734-712-8150 | clearyrk@trinity-health.org |
| Contact: Felicia A Formosa, BS | 734-712-5396 | formosaf@trinity-health.org |
| United States, Michigan | |
| Saint Joseph Mercy Hospital | Recruiting |
| Ann Arbor, Michigan, United States, 48106 | |
| Contact: Robert K Cleary, MD 734-712-8150 clearyrk@trinity-health.org | |
| Contact: Felicia A Formosa, BS 734-712-5396 formosaf@trinity-health.org | |
| Sub-Investigator: Caleb Schroeder, MD | |
| Principal Investigator: | Robert Cleary, MD | Saint Joseph Mercy Health System |
More Information
Additional Information:
No publications provided
| Responsible Party: | Saint Joseph Mercy Health System |
| ClinicalTrials.gov Identifier: | NCT01488045 History of Changes |
| Other Study ID Numbers: | RCCS 262 |
| Study First Received: | December 1, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Saint Joseph Mercy Health System:
|
Colonoscopy Propofol Cancer Screening |
Additional relevant MeSH terms:
|
Colonic Neoplasms Rectal Neoplasms Diverticulum Diverticulosis, Colonic Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Pathological Conditions, Anatomical Midazolam Fentanyl Propofol Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on May 21, 2013