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Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514695
First Posted: January 23, 2012
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McMaster University
Information provided by (Responsible Party):
Khurram Khan, St. Joseph's Healthcare Hamilton
  Purpose
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.

Condition Intervention Phase
Endoscopy Drug: Midazolam Drug: Fentanyl Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Khurram Khan, St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 [ Time Frame: Following procedure up to time of discharge (average of 45 minutes after procedure started) ]
    Recorded by physician completing procedure

  • 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


Enrollment: 139
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514695


Locations
Canada, Ontario
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Investigators
Principal Investigator: Khurram J Khan, MD, BSc, MSc St Joseph's Healthcare Hamilton, McMaster University
  More Information

Responsible Party: Khurram Khan, Assistant Professor of Medicine, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT01514695     History of Changes
Other Study ID Numbers: R.P. 11-3611
First Submitted: January 11, 2012
First Posted: January 23, 2012
Last Update Posted: January 30, 2013
Last Verified: January 2013

Keywords provided by Khurram Khan, St. Joseph's Healthcare Hamilton:
endoscopy
sedation
opioid
narcotic

Additional relevant MeSH terms:
Fentanyl
Midazolam
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action