Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

April 23, 2017 updated by: Elham Tabesh, Isfahan University of Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 5 minutes after the procedure
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
Time Frame: At baseline and at 30 minutes after medication
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 5 minutes after the procedure
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.
Time Frame: 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.
5 minutes after the procedure
Duration of the procedure
Time Frame: From endoscope insertion to endoscope removal
Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.
From endoscope insertion to endoscope removal
Hypotension
Time Frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
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
Time Frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
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
Time Frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isfahan University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vahid Sebghatolahi, MD, Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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Locations

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