NCT01949038

Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diagnostic Esophagogastroduodenoscopy

Interventions

Type	Name	Description
DRUG	Oral alprazolam
DRUG	Sublingual alprazolam
DRUG	Oral placebo
DRUG	Sublingual placebo

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2013-09-24
• Last updated: 2013-10-18

Locations

1 site across 1 country: Iran