Patient Satisfaction With Propofol for Out Patient Colonoscopy

Study Overview
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Brief Summary
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The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.

Detailed Description
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Outpatient colonoscopies are very common, indicated for various reasons, and are more commonly performed in outpatient surgery or endoscopy centers. There is an increase in the use of propofol for sedation because of the short duration of action and quick turn around time. Propofol has been studied extensively for safety and efficacy but patient satisfaction and preference with use has not been well documented in prospective, randomized setting. In the context of the recent changes in healthcare reimbursement where patient satisfaction is becoming an important metric providing data that could improve patient satisfaction is needed. Patients who presented for a colonoscopy with the Principal Investigator were approached to participate in the study. After obtaining consent the patients were randomized to anesthesia with propofol or control without propofol per random number tables provided by the statistician. The anesthesiologist or nurse anesthetist were asked to remove the paper with the assignment from the envelope to determine which medications to give the patient. Pre-op, intra-op, and post-op data were collected by registered nurses blinded to the anesthetic. The day one follow-up phone call was made by the resident who was blinded to the anesthetic. Data were collected in the pre-op, intra-op, and post-op areas by the researchers who were blinded to the medications used.

Official Title
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Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study

Conditions
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Colon Cancer, IBS, Polyps

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients having an outpatient colonoscopy Exclusion Criteria: - High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient center will be excluded.

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Patients in the treatment arm will be given propofol only when having a colonoscopy. | Drug: Propofol<br>* The intervention is to use propofol as anesthesia during a colonoscopy.<br>* Other names: Diprivan;|
| Experimental: Fentanyl Plus Midazolam Only<br>Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy. | Drug: Fentanyl Plus Midazolam<br>* The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.<br>* Other names: Versed;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Satisfaction assessed using self-developed questionnaire. | Patient satisfaction was assessed the day of the procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, colonoscopy, patient satisfaction