Compare Propofol to Fentanyl and Midazolam for Colonoscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Saint Joseph Mercy Health System
Sponsor:
Information provided by (Responsible Party):
Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier:
NCT01488045
First received: December 1, 2011
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Colon Cancer
Rectal Cancer
Colonic Diverticulosis
Drug: Fentanyl
Drug: Propofol
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Saint Joseph Mercy Health System:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: Survey completed 30-45 minutes following colonoscopy procedure ] [ Designated as safety issue: No ]
    Measured by the patient


Secondary Outcome Measures:
  • Patient discomfort [ Time Frame: Survey completed immediately following colonoscopy procedure ] [ Designated as safety issue: No ]
    Measured by the endoscopist


Estimated Enrollment: 290
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Diprivan

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488045

Contacts
Contact: Robert K Cleary, MD 734-712-8150 clearyrk@trinity-health.org
Contact: Janet Obear, RN 734-712-5194 obearj@trinity-health.org

Locations
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Robert K Cleary, MD    734-712-8150    clearyrk@trinity-health.org   
Contact: Janet Obear, RN    734-712-5194    obearj@trinity-health.org   
Sub-Investigator: Caleb Schroeder, MD         
Sponsors and Collaborators
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Robert Cleary, MD Saint Joseph Mercy Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Saint Joseph Mercy Health System
ClinicalTrials.gov Identifier: NCT01488045     History of Changes
Other Study ID Numbers: RCCS 262
Study First Received: December 1, 2011
Last Updated: July 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Joseph Mercy Health System:
Colonoscopy
Propofol
Cancer Screening

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Diverticulum
Diverticulosis, Colonic
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical
Midazolam
Fentanyl
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on July 26, 2014