Clinical trial · Interventional
Compare Propofol to Fentanyl and Midazolam for Colonoscopy
Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colonic Diverticulosis | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Midazolam | Drug | — | UNRESOLVED |
| Propofol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fentanyl and Midazolam
- description
- Fentanyl and Midazolam sedation for colonoscopy discomfort
- interventionNames
- Drug: Fentanyl
- Drug: Midazolam
- type
- ACTIVE_COMPARATOR
- label
- Propofol
- description
- Propofol sedation for colonoscopy discomfort
- interventionNames
- Drug: Propofol
Primary outcomes (1)
- 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")
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available