Compare Propofol to Fentanyl and Midazolam for Colonoscopy

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488045
• Other study ID #: RCCS 262
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2023
• Source: Saint Joseph Mercy Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Diverticulosis
• Diverticulosis, Colonic
• Diverticulum
• Rectal Cancer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Saint Joseph Mercy Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction Scores (Absolute Value)	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).	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	Patient Pain & Discomfort Rating (Absolute Value)	Self-reported by patient via a Visual Analog Scale [0-10], where 0=no pain, 10=worst possible pain	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	Physician Perceptions (Absolute Value)	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.	Measured via physician survey within 30 minutes after the procedure

External Links

•   American Society of Colon and Rectal Surgeons