Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE)

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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy
• Intervention / Treatment: Drug: Midazolam; Drug: Fentanyl; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fentanyl; Fentanyl arm	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
Placebo Comparator: Placebo; Placebo of identical appearance	Drug: Midazolam; Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.; Other: Placebo; One dose of saline (2ml)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: McMaster University
• Investigators: Principal Investigator: Khurram J Khan, MD, BSc, MSc, St Joseph's Healthcare Hamilton, McMaster University

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 30, 2013
• Last Update Submitted That Met QC Criteria: January 28, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: opioid; endoscopy; sedation; narcotic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam
• Other Study ID Numbers: R.P. 11-3611