Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81746-73461
    • Department of Gastroenterology, Alzahra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sublingual alprazolam	Drug: Sublingual alprazolam; Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
Active Comparator: Oral midazolam	Drug: Oral midazolam; Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake	Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.	5 minutes after the procedure
Change in anxiety	Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.	At baseline and at 30 minutes after medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.	Procedure related satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.	5 minutes after the procedure
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.	Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.	5 minutes after the procedure
Duration of the procedure	Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.	From endoscope insertion to endoscope removal
Hypotension	Blood pressure is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Hypotension episode is defined as systolic blood pressure of < 90 mm Hg	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Bradycardia	Heart rate is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Bradycardia episode is defined as heart rate of < 60 bpm.	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Desaturation	Arterial O2 saturation is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Desaturation episode is defined as as arterial oxygen saturation of < 90%.	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Director: Vahid Sebghatolahi, MD, Isfahan University of Medical Sciences

Publications and helpful links

General Publications

• 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 (Actual): September 17, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): February 15, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 23, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 23, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Alprazolam
• Other Study ID Numbers: 395569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data may be available based on the IUMS policy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No