Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Phase 3CompletedNCT01949038

Isfahan University of Medical Sciences220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

220

Conditions

Diagnostic Esophagogastroduodenoscopy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Procedure related pain/discomfort

Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure.

Time frame: Within the first one hour after the procedure

Secondary Outcomes

Pre-procedure anxiety

Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication.

Time frame: Before and 30 minutes after medication

Patients' satisfaction

Procedure related patients' satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure.

Time frame: Within the first one hour after the procedure

Compliance

Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure.

Time frame: Within the first one hour after the procedure

Duration of the procedure

Duration of the procedure is recorded.

Time frame: Within the first one hour after the procedure

Side effects

Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure.

Time frame: Within the first one hour after the procedure

Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes