Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Saint Joseph Mercy Health System

Status: Completed

Conditions: Colonic Diverticulosis; Colon Cancer; Rectal Cancer

Treatments: Drug: Propofol; Drug: Midazolam; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01488045

RCCS 262

Details and patient eligibility

About

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.

Full 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

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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289 participants in 2 patient groups

Fentanyl and Midazolam

Active Comparator group

Description:

Fentanyl and Midazolam sedation for colonoscopy discomfort

Treatment:

Drug: Fentanyl

Drug: Midazolam

Propofol

Active Comparator group

Description:

Propofol sedation for colonoscopy discomfort

Treatment:

Drug: Propofol