Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

Conditions
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Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Propofol
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fentanyl and Midazolam<br>Fentanyl and Midazolam sedation for colonoscopy discomfort | Drug: Fentanyl<br>* 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.<br>* Other names: Matrifen;Drug: Midazolam<br>* 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.<br>* Other names: Versed;|
| Active Comparator: Propofol<br>Propofol sedation for colonoscopy discomfort | Drug: Propofol<br>* 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.<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 
| 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. | Measured via physician survey within 30 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Propofol, Cancer Screening