NCT01514695

Fentanyl Use for Sedation in Esophagogastroduodenoscopy

Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.

Detailed description

Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative \& narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone.

Conditions

• Endoscopy

Interventions

Type	Name	Description
DRUG	Midazolam	Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.
DRUG	Fentanyl	100mcg intravenously given in 2mL syringe at start of procedure
OTHER	Placebo	One dose of saline (2ml)

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-01-23
• Last updated: 2013-01-30

Locations

1 site across 1 country: Canada