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Completed

NCT Number: NCT02937506

Patient Satisfaction With Propofol for Out Patient Colonoscopy

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

The intervention is to use propofol as anesthesia during a colonoscopy.

Other names: Diprivan

Fentanyl Plus Midazolam

Drug

The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.

Other names: Sublimaze, Versed

Primary outcomes

  1. Patient Satisfaction

    Time frame: Patient satisfaction was assessed the day of the procedure.

    Satisfaction assessed using self-developed questionnaire.

Sponsors and collaborators

Lead sponsor

Mount Carmel Health System

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 18, 2016
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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