Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Conditions
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Diagnostic Esophagogastroduodenoscopy

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


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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Discomfort, Anxiety, Satisfaction, Compliance