Patient Satisfaction With Propofol for Out Patient Colonoscopy

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937506
• Other study ID #: 131115-3
• Status: Completed
• Phase: Phase 4
• First received: October 17, 2016
• Last updated: November 30, 2017
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Mount Carmel Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• IBS
• Polyps

Intervention

Drug:
• Propofol
The intervention is to use propofol as anesthesia during a colonoscopy.
• Fentanyl Plus Midazolam
The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.

Locations

Country	Name	City	State
United States	Mount Carmel Health System	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mount Carmel Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Satisfaction assessed using self-developed questionnaire.	Patient satisfaction was assessed the day of the procedure.