Patient Satisfaction With Propofol for Out Patient Colonoscopy

Mount Carmel Health System

Status and phase: Completed; Phase 4

Conditions: Polyps; Colon Cancer; IBS

Treatments: Drug: Fentanyl Plus Midazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02937506

131115-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Fentanyl Plus Midazolam Only

Experimental group

Description:

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

Treatment:

Drug: Fentanyl Plus Midazolam