Know Cancer

forgot password

Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

18 Years
Open (Enrolling)
Colon Cancer, Rectal Cancer, Colonic Diverticulosis

Thank you

Trial Information

Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

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

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

- ASA of IV

- Neurological deficit

- Acute gastrointestinal bleeding

- On anticoagulation agents

- Noncompliance with bowel regiment

- Pregnant women

- Prisoners

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Patient satisfaction

Outcome Description:

Measured by the patient

Outcome Time Frame:

Survey completed 30-45 minutes following colonoscopy procedure

Safety Issue:


Principal Investigator

Robert Cleary, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Joseph Mercy Health System


United States: Institutional Review Board

Study ID:

RCCS 262



Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • Colonic Diverticulosis
  • Colonoscopy
  • Propofol
  • Cancer Screening
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Diverticulum
  • Diverticulosis, Colonic



Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106