Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Phase 2

Completed

• Conditions: Diagnostic Esophagogastroduodenoscopy
• Interventions: Drug: Sublingual alprazolam; Drug: Sublingual placebo; Drug: Oral placebo; Drug: Oral alprazolam

• Registration Number: NCT01949038
• Lead Sponsor: Isfahan University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2013-01
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-16
• Last Update Posted: 2013-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual alprazolam	Sublingual alprazolam	Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
Sublingual placebo	Sublingual placebo	Patients receive one oral dose of placebo at least 30 minutes before the procedure.
Oral placebo	Oral placebo	Patients receive one oral dose of placebo least 30 minutes before the procedure.
Oral alprazolam	Oral alprazolam	Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Primary Outcome Measures

Name	Time	Method
Procedure related pain/discomfort	Within the first one hour after the procedure	Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure.

Secondary Outcome Measures

Name	Time	Method
Side effects	Within the first one hour after the procedure	Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure.
Duration of the procedure	Within the first one hour after the procedure	Duration of the procedure is recorded.
Pre-procedure anxiety	Before and 30 minutes after medication	Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication.
Patients' satisfaction	Within the first one hour after the procedure	Procedure related patients' satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure.
Compliance	Within the first one hour after the procedure	Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure.

Trial Locations

Locations (1)

Private Outpatient Clinic of Gastroenterology; 🇮🇷 Isfahan, Iran, Islamic Republic of