Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE)
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale [ Time Frame: Within 72 hours of procedure ] [ Designated as safety issue: No ]Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.
- 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) ] [ Designated as safety issue: No ]
- Patient willingness to repeat procedure [ Time Frame: Asked within 72 hours of procedure ] [ Designated as safety issue: Yes ]
- Presence of significant retching [ Time Frame: Following procedure up to time of discharge (average of 45 minutes after procedure started) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Canada, Ontario | |
| St Joseph's Healthcare Hamilton | |
| Hamilton, Ontario, Canada, L8N4A6 | |
| Principal Investigator: | Khurram J Khan, MD, BSc, MSc | St Joseph's Healthcare Hamilton, McMaster University |
More Information
No publications provided
| 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 |
| Study First Received: | January 11, 2012 |
| Last Updated: | January 28, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by St. Joseph's Healthcare Hamilton:
|
endoscopy sedation opioid narcotic |
Additional relevant MeSH terms:
|
Midazolam Fentanyl Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives |
Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013