N/A
N=289
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Colon Cancer · Rectal Cancer · Colonic Diverticulosis
Bottom Line
View on ClinicalTrials.gov: NCT01488045 ↗Enrolled (actual)
289
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Patient Satisfaction Scores (Absolute Value) — 98.0; 83.9; 98.1; 79.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fentanyl (Drug); Propofol (Drug); Midazolam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Trinity Health Michigan
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Satisfaction Scores (Absolute Value) |
98.0; 83.9; 98.1; 79.2; 100.0; 79.5 | — |
| SECONDARY Patient Pain & Discomfort Rating (Absolute Value) |
0.2; 2.4; 0.8; 1.9; 0.7; 1.2 | — |
| SECONDARY Physician Perceptions (Absolute Value) |
1.3; 3.7; 0.6; 2.1; 4.4; 5.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01488045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.