Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

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 Overview

• Status: Completed
• Conditions: Diagnostic Esophagogastroduodenoscopy
• Intervention / Treatment: Drug: Oral placebo; Drug: Sublingual placebo; Drug: Sublingual alprazolam; Drug: Oral alprazolam

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of
    • Private Outpatient Clinic of Gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Oral placebo; Patients receive one oral dose of placebo least 30 minutes before the procedure.	Drug: Oral placebo
PLACEBO_COMPARATOR: Sublingual placebo; Patients receive one oral dose of placebo at least 30 minutes before the procedure.	Drug: Sublingual placebo
ACTIVE_COMPARATOR: Sublingual alprazolam; Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.	Drug: Sublingual alprazolam
ACTIVE_COMPARATOR: Oral alprazolam; Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.	Drug: Oral alprazolam

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-procedure anxiety	Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication.	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.	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.	Within the first one hour after the procedure
Duration of the procedure	Duration of the procedure is recorded.	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.	Within the first one hour after the procedure

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Ahmad Shavakhi, M.D., Isfahan University of Medical Sciences

Publications and helpful links

General Publications

• Hedenbro JL, Ekelund M, Aberg T, Lindblom A. Oral sedation for diagnostic upper endoscopy. Endoscopy. 1991 Jan;23(1):8-10. doi: 10.1055/s-2007-1010598.
• Shavakhi A, Soleiman S, Gholamrezaei A, Khodadoostan M, Shavakhi S, Tahery A, Minakari M. Premedication with sublingual or oral alprazolam in adults undergoing diagnostic upper gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):633-9. doi: 10.1055/s-0034-1377305. Epub 2014 Jun 30.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (ESTIMATE): September 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 18, 2013
• Last Update Submitted That Met QC Criteria: October 16, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Satisfaction; Compliance; Discomfort
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Alprazolam
• Other Study ID Numbers: 391009