Title

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

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    600
The primary purpose of this study is to determine if patient satisfaction with propofol is better than with non-propofol anesthesia for outpatient colonoscopies.
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 Started
Nov 30
2013
Primary Completion
Mar 31
2016
Study Completion
Aug 31
2016
Results Posted
Sep 27
2017
Last Update
Dec 26
2017

Drug Propofol

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

  • Other names: Diprivan

Drug Fentanyl Plus Midazolam

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

  • Other names: Sublimaze, Versed

Propofol Experimental

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

Fentanyl Plus Midazolam Only Experimental

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

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.

Summary

Propofol

Fentanyl Plus Midazolam Only

All Events

Event Type Organ System Event Term Propofol Fentanyl Plus Midazolam Only

Patient Satisfaction

Satisfaction assessed using self-developed questionnaire.

Propofol

Fentanyl Plus Midazolam Only

Total

600
Participants

Age, Continuous

61.2
Years (Mean)
Standard Deviation: 9.6

Sex: Female, Male

Overall Study

Propofol

Fentanyl Plus Midazolam Only