Fentanyl Use for Sedation in Esophagogastroduodenoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Endoscopy

Intervention / Treatment
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* Drug: Midazolam
* Drug: Fentanyl
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl<br>Fentanyl arm | Drug: Midazolam<br>* Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.<br>Drug: Fentanyl<br>* 100mcg intravenously given in 2mL syringe at start of procedure<br>|
| Placebo Comparator: Placebo<br>Placebo of identical appearance | Drug: Midazolam<br>* Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.<br>Other: Placebo<br>* One dose of saline (2ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale | Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure. | Within 72 hours of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale |  | Following procedure up to time of discharge (average of 45 minutes after procedure started) | 
| Patient willingness to repeat procedure |  | Asked within 72 hours of procedure | 
| Presence of significant retching | Recorded by physician completing procedure | Following procedure up to time of discharge (average of 45 minutes after procedure started) | 
| Presence of adverse events | Any adverse event during procedure up until patient leaves endoscopy unit | Following procedure up to time of discharge (average of 45 minutes after procedure started) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, opioid, narcotic, endoscopy