Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
Overview
- Phase
- Not Applicable
- Intervention
- Fentanyl
- Conditions
- Colon Cancer
- Sponsor
- Saint Joseph Mercy Health System
- Enrollment
- 289
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction Scores (Absolute Value)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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
Investigators
Eligibility 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
Arms & Interventions
Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
Intervention: Fentanyl
Fentanyl and Midazolam
Fentanyl and Midazolam sedation for colonoscopy discomfort
Intervention: Midazolam
Propofol
Propofol sedation for colonoscopy discomfort
Intervention: Propofol
Outcomes
Primary Outcomes
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
- Physician Perceptions (Absolute Value)(Measured via physician survey within 30 minutes after the procedure)
- Patient Pain & Discomfort Rating (Absolute Value)(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"))