Endoscopy
Conditions
Keywords
endoscopy, sedation, opioid, narcotic
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.
Interventions
DRUGMidazolam
Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.
DRUGFentanyl
100mcg intravenously given in 2mL syringe at start of procedure
OTHERPlacebo
One dose of saline (2ml)
Sponsors
McMaster University
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale | Within 72 hours of procedure | Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Following procedure up to time of discharge (average of 45 minutes after procedure started) | Recorded by physician completing procedure |
| Presence of adverse events | 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 |
Countries
Canada
Outcome results
None listed