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Completed

NCT Number: NCT01514695

Fentanyl Use for Sedation in Esophagogastroduodenoscopy

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.

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Key information

Conditions

Endoscopy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

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

Fentanyl

Drug

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

Placebo

Other

One dose of saline (2ml)

Primary outcomes

  1. Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale

    Time frame: Within 72 hours of procedure

    Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.

Secondary outcomes

  1. 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)

  2. Patient willingness to repeat procedure

    Time frame: Asked within 72 hours of procedure

  3. Presence of significant retching

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

    Recorded by physician completing procedure

  4. Presence of adverse events

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

    Any adverse event during procedure up until patient leaves endoscopy unit

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • McMaster University

Registry information

Official study title

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

Acronym: FUSE

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2012
Registry last updated
Jan 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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