Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Sponsor

Saint Joseph Mercy Health System (Other)

Overall Status

Unknown status

CT.gov ID

NCT01488045

Collaborator

(none)

290

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Rectal Cancer Colonic Diverticulosis	Drug: Fentanyl Drug: Propofol Drug: Midazolam	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Diprivan

Arm

Intervention/Treatment

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 Names:

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 Names:

Diprivan

Outcome Measures

Primary Outcome Measures

Patient satisfaction [Survey completed 30-45 minutes following colonoscopy procedure]
Measured by the patient

Secondary Outcome Measures

Patient discomfort [Survey completed immediately following colonoscopy procedure]
Measured by the endoscopist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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