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Patient Satisfaction With Propofol for Out Patient Colonoscopy

Primary Purpose

Colon Cancer, IBS, Polyps

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propofol
Fentanyl Plus Midazolam
Sponsored by
Mount Carmel Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring propofol, colonoscopy, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mount Carmel Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Propofol

Fentanyl Plus Midazolam Only

Arm Description

Patients in the treatment arm will be given propofol only when having a colonoscopy.

Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.

Outcomes

Primary Outcome Measures

Patient Satisfaction
Satisfaction assessed using self-developed questionnaire.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2016
Last Updated
November 30, 2017
Sponsor
Mount Carmel Health System
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1. Study Identification

Unique Protocol Identification Number
NCT02937506
Brief Title
Patient Satisfaction With Propofol for Out Patient Colonoscopy
Official Title
Patient Satisfaction With Propofol for Out Patient Colonoscopy: A Prospective, Randomized, Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Carmel Health System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, IBS, Polyps
Keywords
propofol, colonoscopy, patient satisfaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
Patients in the treatment arm will be given propofol only when having a colonoscopy.
Arm Title
Fentanyl Plus Midazolam Only
Arm Type
Experimental
Arm Description
Patients in the control arm will receive only the standard of care medications, fentanyl and midazolam when having a colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
The intervention is to use propofol as anesthesia during a colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Fentanyl Plus Midazolam
Other Intervention Name(s)
Sublimaze, Versed
Intervention Description
The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Satisfaction assessed using self-developed questionnaire.
Time Frame
Patient satisfaction was assessed the day of the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anantha Padmanabhan, MD
Organizational Affiliation
Mount Carmel Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Carmel Health System
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Patient Satisfaction With Propofol for Out Patient Colonoscopy

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