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Diagnostic esophagogastroduodenoscopy is an uncomfortable and stressful procedure for most of the patients. Various methods are available for sedation during this procedure. Because of some side effects related to intravenous administration of sedatives, oral administration of these drugs is under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety. Hence, we determine the efficacy of oral and sublingual alprazolam as for sedation during this procedure. We hypothesize that sublingual alprazolam is more effective than that oral form and both forms more effective than placebo in reducing anxiety and pain/discomfort related to the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral placebo | Placebo Comparator | Patients receive one oral dose of placebo least 30 minutes before the procedure. |
|
| Sublingual placebo | Placebo Comparator | Patients receive one oral dose of placebo at least 30 minutes before the procedure. |
|
| Sublingual alprazolam | Active Comparator | Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure. |
|
| Oral alprazolam | Active Comparator | Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral alprazolam | Drug |
| ||
| Sublingual alprazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure related pain/discomfort | Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure. | Within the first one hour after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-procedure anxiety | Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication. | Before and 30 minutes after medication |
| Patients' satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Shavakhi, M.D. | Isfahan University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Outpatient Clinic of Gastroenterology | Isfahan | Isfahan | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2009843 | Background | Hedenbro JL, Ekelund M, Aberg T, Lindblom A. Oral sedation for diagnostic upper endoscopy. Endoscopy. 1991 Jan;23(1):8-10. doi: 10.1055/s-2007-1010598. | |
| 24977401 | Derived | Shavakhi A, Soleiman S, Gholamrezaei A, Khodadoostan M, Shavakhi S, Tahery A, Minakari M. Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):633-9. doi: 10.1055/s-0034-1377305. Epub 2014 Jun 30. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D010549 | Personal Satisfaction |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Oral placebo | Drug |
|
| Sublingual placebo | Drug |
|
Procedure related patients' satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure.
| Within the first one hour after the procedure |
| Compliance | Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure. | Within the first one hour after the procedure |
| Duration of the procedure | Duration of the procedure is recorded. | Within the first one hour after the procedure |
| Side effects | Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure. | Within the first one hour after the procedure |
| D001519 | Behavior |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D006571 | Heterocyclic Compounds |