Compare Propofol to Fentanyl and Midazolam for Colonoscopy

NCT01488045 | Completed Results

• 1 other identifier: RCCS 262
• Study Type: interventional
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician.

Conditions

Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Keywords

Colonoscopy; Propofol; Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction Scores (Absolute Value)

  Measured by the patient using a 100-point Visual Analog Scale (VAS) \[0-100%\] with higher score indicating higher agreement with the statement/question. Higher agreement scores would indicate higher satisfaction (better outcome).

  Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure")

Secondary Outcomes (2)

• Patient Pain & Discomfort Rating (Absolute Value)

  Survey administered in the recovery room up to 30 minutes following procedure ("Recovery room"), and a follow-up patient survey was carried out by telephone between 1 and 5 days postprocedure ("1-5 d postprocedure")

• Physician Perceptions (Absolute Value)

  Measured via physician survey within 30 minutes after the procedure

Study Arms (2)

Fentanyl and Midazolam

ACTIVE COMPARATOR

Fentanyl and Midazolam sedation for colonoscopy discomfort

Drug: Fentanyl; Drug: Midazolam

Propofol

ACTIVE COMPARATOR

Propofol sedation for colonoscopy discomfort

Drug: Propofol

Interventions

Fentanyl DRUG

Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.

Also known as: Durogesic, Duragesic, Matrifen

Fentanyl and Midazolam

Propofol DRUG

Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.

Also known as: Diprivan

Propofol

Midazolam DRUG

Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.

Also known as: Versed

Fentanyl and Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Elective outpatient colonoscopy
• American Society of Anesthesiology Class (ASA) \< IV

You may not qualify if:

• Age \< 18
• Inpatient status
• Emergency procedure
• History of colonic or rectal resection
• History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam
• ASA of IV
• Neurological deficit
• Acute gastrointestinal bleeding
• On anticoagulation agents
• Noncompliance with bowel regiment
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Trinity Health Michigan: lead

Study Sites (1)

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Related Links

• American Society of Colon and Rectal Surgeons

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Diverticulosis, Colonic

Interventions

Fentanyl; Propofol; 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; Rectal Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This is a single-institution, single endoscopist study and is limited by the inability to perform blinding of the endoscopist.The endoscopist could not be blinded to treatment because of the presence of an anesthesia provider in the colonoscopy suite for the Propofol group. Anesthesia providers were not present for the midazolam/fentanyl group because we wanted to mimic and compare 2 of the most commonly used practice strategies as much as possible.

Results Point of Contact

• Title: Robert K. Cleary, MD
• Organization: St. Joseph Mercy Hospital

Robert.Cleary@trinity-health.org

734.712.8150

Study Officials

• Robert Cleary, MD

  Trinity Health Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 8, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 23, 2023
• Results First Posted: May 23, 2023

Record last verified: 2023-04

Locations

US (1)