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Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

NCT01949038 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2013-10-18

No results posted yet for this study

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

DRUG

Oral alprazolam

DRUG

Sublingual alprazolam

DRUG

Oral placebo

DRUG

Sublingual placebo

Sponsors & Collaborators

  • Isfahan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ahmad Shavakhi, M.D. · Isfahan University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01949038 on ClinicalTrials.gov