Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diagnostic Esophagogastroduodenoscopy

Treatments: Drug: Sublingual placebo; Drug: Oral alprazolam; Drug: Oral placebo; Drug: Sublingual alprazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01949038

391009

Details and patient eligibility

About

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.

Enrollment: 220 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: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 4 patient groups, including a placebo group

Oral placebo

Placebo Comparator group

Description:

Patients receive one oral dose of placebo least 30 minutes before the procedure.

Treatment:

Drug: Oral placebo

Sublingual placebo

Placebo Comparator group

Description:

Patients receive one oral dose of placebo at least 30 minutes before the procedure.

Treatment:

Drug: Sublingual placebo

Sublingual alprazolam

Active Comparator group

Description:

Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Treatment:

Drug: Sublingual alprazolam

Oral alprazolam

Active Comparator group

Description:

Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Treatment:

Drug: Oral alprazolam