Fentanyl Use for Sedation in Esophagogastroduodenoscopy

St. Joseph's Healthcare Hamilton139 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

139

Conditions

Endoscopy

Interventions

MidazolamDRUG

Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.

FentanylDRUG

100mcg intravenously given in 2mL syringe at start of procedure

PlaceboOTHER

One dose of saline (2ml)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Within 72 hours of procedure

Secondary Outcomes

Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale

Time frame: Following procedure up to time of discharge (average of 45 minutes after procedure started)

Patient willingness to repeat procedure

Time frame: Asked within 72 hours of procedure

Presence of significant retching

Recorded by physician completing procedure

Time frame: 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

Time frame: Following procedure up to time of discharge (average of 45 minutes after procedure started)

Data from ClinicalTrials.gov

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