Clinical trial NCT01488045: Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Official title: Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Colonic Diverticulosis
Keywords: Colonoscopy
Propofol
Cancer Screening
Lead sponsor: Saint Joseph Mercy Health System
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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
* Pregnant women
* Prisoners

Primary outcomes:
measure: Patient Satisfaction Scores (Absolute Value)
timeFrame: 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 outcomes:
measure: Patient Pain & Discomfort Rating (Absolute Value)
timeFrame: 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")
measure: Physician Perceptions (Absolute Value)
timeFrame: Measured via physician survey within 30 minutes after the procedure
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
Study officials:
affiliation: Saint Joseph Mercy Health System
name: Robert Cleary, MD
role: PRINCIPAL_INVESTIGATOR
References: