Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: Alprazolam

Criteria

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