Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Not Applicable

Completed

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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol sedation for colonoscopy discomfort
Fentanyl and Midazolam	Fentanyl	Fentanyl and Midazolam sedation for colonoscopy discomfort
Fentanyl and Midazolam	Midazolam	Fentanyl and Midazolam sedation for colonoscopy discomfort

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Scores (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")	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 Outcome Measures

Name	Time	Method
Physician Perceptions (Absolute Value)	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.
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")	Self-reported by patient via a Visual Analog Scale \[0-10\], where 0=no pain, 10=worst possible pain