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OpenTrials
Completed

NCT Number: NCT01488045

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

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.

Other names: Durogesic, Duragesic, Matrifen

Propofol

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.

Other names: Diprivan

midazolam

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.

Other names: Versed

Primary outcomes

  1. Patient Satisfaction Scores (Absolute Value)

    Time frame: 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")

    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).

Secondary outcomes

  1. Patient Pain & Discomfort Rating (Absolute Value)

    Time frame: 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")

    Self-reported by patient via a Visual Analog Scale [0-10], where 0=no pain, 10=worst possible pain

  2. Physician Perceptions (Absolute Value)

    Time frame: Measured via physician survey within 30 minutes after the procedure

    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.

Sponsors and collaborators

Lead sponsor

Trinity Health Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2011
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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