Clinical trial NCT01514695: Fentanyl Use for Sedation in Esophagogastroduodenoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endoscopy
Keywords: endoscopy
sedation
opioid
narcotic
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2012-01-23
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale
timeFrame: Within 72 hours of procedure
Secondary outcomes:
measure: Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale
timeFrame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
measure: Patient willingness to repeat procedure
timeFrame: Asked within 72 hours of procedure
measure: Presence of significant retching
timeFrame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
measure: Presence of adverse events
timeFrame: Following procedure up to time of discharge (average of 45 minutes after procedure started)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: St Joseph's Healthcare Hamilton, McMaster University
name: Khurram J Khan, MD, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: