Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diagnostic Esophagogastroduodenoscopy

Treatments: Drug: Sublingual alprazolam; Drug: Oral midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03130842

395569

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Sublingual alprazolam

Active Comparator group

Treatment:

Drug: Sublingual alprazolam

Oral midazolam

Active Comparator group

Treatment:

Drug: Oral midazolam