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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Experimental | Fentanyl arm |
|
| Placebo | Placebo Comparator | Placebo of identical appearance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale | Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure. | Within 72 hours of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khurram J Khan, MD, BSc, MSc | St Joseph's Healthcare Hamilton, McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Fentanyl | Drug | 100mcg intravenously given in 2mL syringe at start of procedure |
|
| Placebo | Other | One dose of saline (2ml) |
|
| Presence of significant retching | Recorded by physician completing procedure | Following procedure up to time of discharge (average of 45 minutes after procedure started) |
| Presence of adverse events | Any adverse event during procedure up until patient leaves endoscopy unit | Following procedure up to time of discharge (average of 45 minutes after procedure started) |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |