Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults

Conditions
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Diagnostic Esophagogastroduodenoscopy

Intervention / Treatment
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* Drug: Sublingual alprazolam
* Drug: Oral midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referring for upper GI endoscopy Age 18 to 65 years First experience of upper GI endoscopy Class I or II of American Anesthesiology Association Willingness to participate Exclusion Criteria: Severe psychiatric, neurological, cardio-vascular, or renal disorders History of allergy or intolerance to benzodiazepines or lidocaine History of upper GI surgery Pregnancy or lactation GI anomalia during endoscopy Need for therapeutic procedures during endoscopy Active bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sublingual alprazolam<br> | Drug: Sublingual alprazolam<br>* Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.<br>|
| Active Comparator: Oral midazolam<br> | Drug: Oral midazolam<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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. |