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Patient Satisfaction With Propofol for Out Patient Colonoscopy

NCT ID: NCT02937506

Last Updated: 2017-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-08-31

Brief Summary

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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

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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

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Colon Cancer IBS Polyps

Keywords

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propofol colonoscopy patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

Fentanyl Plus Midazolam Only

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

Group Type EXPERIMENTAL

Fentanyl Plus Midazolam

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Fentanyl Plus Midazolam

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

Intervention Type DRUG

Other Intervention Names

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Diprivan Sublimaze Versed

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Carmel Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anantha Padmanabhan, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Carmel Health System

Locations

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Mount Carmel Health System

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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131115-3

Identifier Type: -

Identifier Source: org_study_id