Patient Satisfaction With Propofol for Out Patient Colonoscopy

Phase 4

Completed

• Conditions: IBS; Polyps; Colon Cancer
• Interventions: Drug: Fentanyl Plus Midazolam; Drug: Propofol

• Registration Number: NCT02937506
• Lead Sponsor: Mount Carmel Health System

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2016-03
• Study Completion: 2016-08
• Status Verified: 2016-10
• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Results First Submitted: 2017-08-30
• Results First Submitted QC: 2017-08-30
• Results First Posted: 2017-09-27
• Last Update Submitted: 2017-11-30
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Patients having an outpatient colonoscopy

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Exclusion Criteria

• High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient center will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl Plus Midazolam Only	Fentanyl Plus Midazolam	Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.
Propofol	Propofol	Patients in the treatment arm will be given propofol only when having a colonoscopy.

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Patient satisfaction was assessed the day of the procedure.	Satisfaction assessed using self-developed questionnaire.

Trial Locations

Locations (1)

Mount Carmel Health System; 🇺🇸 Columbus, Ohio, United States