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Clinical Trials/NCT02937506
NCT02937506
Completed
Phase 4

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

Mount Carmel Health System1 site in 1 country600 target enrollmentNovember 2013

Overview

Phase
Phase 4
Intervention
Propofol
Conditions
Colon Cancer
Sponsor
Mount Carmel Health System
Enrollment
600
Locations
1
Primary Endpoint
Patient Satisfaction
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
August 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Arms & Interventions

Propofol

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

Intervention: Propofol

Fentanyl Plus Midazolam Only

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

Intervention: Fentanyl Plus Midazolam

Outcomes

Primary Outcomes

Patient Satisfaction

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

Satisfaction assessed using self-developed questionnaire.

Study Sites (1)

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