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Diagnostic EsophagogastroduodenoscopyPhase 2/3NCT01949038

Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

A Phase 2/3 study testing Oral alprazolam and Sublingual alprazolam in people with Diagnostic Esophagogastroduodenoscopy, run by Isfahan University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diagnostic Esophagogastroduodenoscopy
What is being tested?
Oral alprazolam and Sublingual alprazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteIran
Study dates
Sep 2011to Jan 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Private Outpatient Clinic of Gastroenterology

    Isfahan, Isfahan

Other trials in Iran

About this study

Official title: 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.

Being tested
Oral alprazolam, Sublingual alprazolam, Oral placebo, Sublingual placebo
Keywords
Pain, Discomfort, Anxiety, Satisfaction, Compliance
Medical subject headings
Pain, Anxiety Disorders, Personal Satisfaction, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral alprazolamDrug

  • Sublingual alprazolamDrug

  • Oral placeboDrug

  • Sublingual placeboDrug

Study groups in NCT01949038
Study groupRoleWhat they receive
Oral placeboPlacebo comparatorPatients receive one oral dose of placebo least 30 minutes before the procedure.
Receives: Drug: Oral placebo
Sublingual placeboPlacebo comparatorPatients receive one oral dose of placebo at least 30 minutes before the procedure.
Receives: Drug: Sublingual placebo
Sublingual alprazolamActive comparatorPatients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
Receives: Drug: Sublingual alprazolam
Oral alprazolamActive comparatorPatients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
Receives: Drug: Oral alprazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure related pain/discomfort

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

    Measured: Within the first one hour after the procedure

Secondary outcomes (5)

  1. Pre-procedure anxiety

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

    Measured: Before and 30 minutes after medication

  2. Patients' satisfaction

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

    Measured: Within the first one hour after the procedure

  3. Compliance

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

    Measured: Within the first one hour after the procedure

  4. Duration of the procedure

    Duration of the procedure is recorded.

    Measured: Within the first one hour after the procedure

  5. Side effects

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

    Measured: Within the first one hour after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2012
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01949038
Sponsor's protocol ID
391009
Status last verified
Oct 2013
First submitted
17 Sep 2013
Last updated
18 Oct 2013
Results posted
No
Data monitoring committee
No

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.

    PubMed 2009843

  • 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.

    PubMed 24977401

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral alprazolam and Sublingual alprazolam in people with Diagnostic Esophagogastroduodenoscopy, run by Isfahan University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure related pain/discomfort (time frame: Within the first one hour after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01949038, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2013.

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