Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE)

St. Joseph's Healthcare Hamilton

Status and phase: Completed; Phase 4

Conditions: Endoscopy

Treatments: Drug: Midazolam; Drug: Fentanyl; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01514695

R.P. 11-3611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• outpatient elective upper endoscopy
• age 18-65
• able to give consent

Exclusion criteria

• mental incompetency
• pregnancy
• weight <55kg or 110 lbs
• emergent procedures,
• known hypersensitivity or allergy to fentanyl or midazolam
• chronic use of benzodiazepines or opioids
• patients known a priori to require therapeutic interventions in conjunction with their EGD
• patients to have major cardiorespiratory comorbidities, obstructive sleep apnea, liver cirrhosis, or renal failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 2 patient groups, including a placebo group

Fentanyl

Experimental group

Description:

Fentanyl arm

Treatment:

Drug: Fentanyl

Drug: Midazolam

Placebo

Placebo Comparator group

Description:

Placebo of identical appearance

Treatment:

Other: Placebo

Drug: Midazolam