Compare Propofol to Fentanyl and Midazolam for Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer; Colon Cancer; Colonic Diverticulosis
• Intervention / Treatment: Drug: Fentanyl; Drug: Midazolam; Drug: Propofol

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

• Study Type: Interventional
• Enrollment (Actual): 289
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl and Midazolam; Fentanyl and Midazolam sedation for colonoscopy discomfort	Drug: 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.; Other Names: Durogesic; Duragesic; Matrifen; 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.; Other Names: Versed
Active Comparator: Propofol; Propofol sedation for colonoscopy discomfort	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.; Other Names: Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain & Discomfort Rating (Absolute Value)	Self-reported by patient via a Visual Analog Scale [0-10], where 0=no pain, 10=worst possible pain	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)	Self-reported Physician/Endoscopist perceptions Measured via Visual Analog Scale [0-10] of: Highest pain, Average pain, Difficulty of procedure, Bowel preparation, Patient movement. A score of 0 on the scale=no pain/difficulty, while a score of 10=worst possible pain/difficulty/severity. The higher the score the worse the outcome.	Measured via physician survey within 30 minutes after the procedure

Collaborators and Investigators

• Sponsor: Saint Joseph Mercy Health System
• Investigators: Principal Investigator: Robert Cleary, MD, Saint Joseph Mercy Health System

Publications and helpful links

Helpful Links

• American Society of Colon and Rectal Surgeons

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 1, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Colonoscopy; Propofol; Cancer Screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Propofol
• Other Study ID Numbers: RCCS 262