Patient Satisfaction With Propofol for Out Patient Colonoscopy

NCT02937506 | Completed Phase 4 Results DMC

• 1 other identifier: 131115-3
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; IBS; Polyps

Keywords

propofol; colonoscopy; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Satisfaction assessed using self-developed questionnaire.

  Patient satisfaction was assessed the day of the procedure.

Study Arms (2)

Propofol

EXPERIMENTAL

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

Drug: Propofol

Fentanyl Plus Midazolam Only

EXPERIMENTAL

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

Drug: Fentanyl Plus Midazolam

Interventions

Propofol DRUG

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

Also known as: Diprivan

Propofol

Fentanyl Plus Midazolam DRUG

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

Also known as: Sublimaze, Versed

Fentanyl Plus Midazolam Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients having an outpatient colonoscopy

You may not qualify if:

• \- High risk patients (ASA IV \& V) who are not candidates for colonoscopy in an outpatient center will be excluded.

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43213, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Polyps; Patient Satisfaction

Interventions

Propofol; Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Anantha Padmanabhan, MD
• Organization: Mount Carmel Health System

apadmanabhan@mchs.com

614-234-1079

Study Officials

• Anantha Padmanabhan, MD

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 18, 2016
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 26, 2017
• Results First Posted: September 27, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)