Compare Propofol to Fentanyl and Midazolam for Colonoscopy

NCT ID: NCT01488045

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 289 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-03-31

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.

Detailed Description

Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects.

Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects

Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure.

Other Variables of Interest.

• Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge.
• Difficulty of procedure rated by the physician on a scale of 0-10
• Colonoscopy completion rates (intubation of cecum).
• Complications including oxygen desaturation or hypotension.
• Cost of the two medication regiments

Conditions

Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Fentanyl and Midazolam

Fentanyl and Midazolam sedation for colonoscopy discomfort

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: 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.

Midazolam

Intervention Type: 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.

Propofol

Propofol sedation for colonoscopy discomfort

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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.

Interventions

Fentanyl

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.

Intervention Type: DRUG

Propofol

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.

Intervention Type: DRUG

Midazolam

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.

Intervention Type: DRUG

Other Intervention Names

Durogesic; Duragesic; Matrifen; Diprivan; Versed

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trinity Health Michigan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Cleary, MD

Role: PRINCIPAL_INVESTIGATOR

Trinity Health Michigan

Locations

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Countries

United States

Related Links

http://www.fascrs.org

American Society of Colon and Rectal Surgeons

Other Identifiers

RCCS 262

Identifier Type: -

Identifier Source: org_study_id