Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Primary Purpose
Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
Propofol
Midazolam
Sponsored by
About this trial
This is an interventional supportive care trial for Colon Cancer focused on measuring Colonoscopy, Propofol, Cancer Screening
Eligibility Criteria
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
Sites / Locations
- Saint Joseph Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fentanyl and Midazolam
Propofol
Arm Description
Fentanyl and Midazolam sedation for colonoscopy discomfort
Propofol sedation for colonoscopy discomfort
Outcomes
Primary Outcome Measures
Patient Satisfaction Scores (Absolute Value)
Measured by the patient using a 100-point Visual Analog Scale (VAS) [0-100%] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).
Secondary Outcome Measures
Patient Pain & Discomfort Rating (Absolute Value)
Self-reported by patient via a Visual Analog Scale [0-10], where 0=no pain, 10=worst possible pain
Physician Perceptions (Absolute Value)
Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale [0-10] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome.
Full Information
NCT ID
NCT01488045
First Posted
December 1, 2011
Last Updated
April 27, 2023
Sponsor
Saint Joseph Mercy Health System
1. Study Identification
Unique Protocol Identification Number
NCT01488045
Brief Title
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Official Title
Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Joseph Mercy Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Rectal Cancer, Colonic Diverticulosis
Keywords
Colonoscopy, Propofol, Cancer Screening
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fentanyl and Midazolam
Arm Type
Active Comparator
Arm Description
Fentanyl and Midazolam sedation for colonoscopy discomfort
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol sedation for colonoscopy discomfort
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Durogesic, Duragesic, Matrifen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Satisfaction Scores (Absolute Value)
Description
Measured by the patient using a 100-point Visual Analog Scale (VAS) [0-100%] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).
Time Frame
Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure")
Secondary Outcome Measure Information:
Title
Patient Pain & Discomfort Rating (Absolute Value)
Description
Self-reported by patient via a Visual Analog Scale [0-10], where 0=no pain, 10=worst possible pain
Time Frame
Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure")
Title
Physician Perceptions (Absolute Value)
Description
Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale [0-10] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome.
Time Frame
Measured via physician survey within 30 minutes after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Cleary, MD
Organizational Affiliation
Saint Joseph Mercy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fascrs.org
Description
American Society of Colon and Rectal Surgeons
Learn more about this trial
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
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