Patient Satisfaction With Propofol for Out Patient Colonoscopy

November 30, 2017 updated by: Mount Carmel Health System

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Mount Carmel Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Carmel Health System

Investigators

  • Principal Investigator: Anantha Padmanabhan, MD, Mount Carmel Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

December 26, 2017

Last Update Submitted That Met QC Criteria

November 30, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 131115-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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