NCT02937506

Patient Satisfaction With Propofol for Out Patient Colonoscopy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Mount Carmel Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colon Cancer
• IBS
• Polyps

Interventions

Type	Name	Description
DRUG	Propofol	The intervention is to use propofol as anesthesia during a colonoscopy.
DRUG	Fentanyl Plus Midazolam	The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-03-01
• Completion: 2016-08-01
• First posted: 2016-10-18
• Last updated: 2017-12-26
• Results posted: 2017-09-27

Locations

1 site across 1 country: United States