drugset / Trial / NCT03130842

Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

NCT03130842

Phase 2/3 Completed 136 enrolled Isfahan University of Medical Sciences
Non-randomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2016-09-17
Primary completion
2017-02-15
Completion
2017-02-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Alprazolam Small molecule 0.5 mg Other
Comparator Midazolam Small molecule 7.5 mg Oral

Indications

No indication recorded.