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Diagnostic upper GI endoscopy can be uncomfortable and stressful for many 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. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam in reducing anxiety and pain/discomfort related to the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual alprazolam | Active Comparator |
| |
| Oral midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual alprazolam | Drug | Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake | Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. | 5 minutes after the procedure |
| Change in anxiety | Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication. | At baseline and at 30 minutes after medication |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. | Procedure related satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. | 5 minutes after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vahid Sebghatolahi, MD | Isfahan University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Alzahra Hospital | Isfahan | 81746-73461 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24977401 | Background | 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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Data may be available based on the IUMS policy
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Oral midazolam | Drug | Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure. |
|
| Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake. |
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake. |
| 5 minutes after the procedure |
| Duration of the procedure | Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal. | From endoscope insertion to endoscope removal |
| Hypotension | Blood pressure is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Hypotension episode is defined as systolic blood pressure of < 90 mm Hg | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. |
| Bradycardia | Heart rate is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Bradycardia episode is defined as heart rate of < 60 bpm. | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. |
| Desaturation | Arterial O2 saturation is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Desaturation episode is defined as as arterial oxygen saturation of < 90%. | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. |
| D006571 | Heterocyclic Compounds |