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CompletedNCT01949038Updated Oct 18, 2013

Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

A Phase 2/3 interventional study of Oral alprazolam and Sublingual alprazolam in Diagnostic Esophagogastroduodenoscopy, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-18.

Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Prevention

Phase
Phase 2/3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diagnostic Esophagogastroduodenoscopy

Keywords

  • Pain
  • Discomfort
  • Anxiety
  • Satisfaction
  • Compliance
03

In context

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • 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

Interventions

  • DrugOral alprazolam
  • DrugSublingual alprazolam
  • DrugOral placebo
  • DrugSublingual placebo
06

What researchers measure

Primary outcomes

  1. Procedure related pain/discomfort

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

    Time frame: Within the first one hour after the procedure

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Within the first one hour after the procedure

  4. Duration of the procedure

    Duration of the procedure is recorded.

    Time frame: 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.

    Time frame: Within the first one hour after the procedure

07

Study locations

1 site
  • Private Outpatient Clinic of Gastroenterology
    Isfahan, Iran, Islamic Republic of
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01949038
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Ali Gholamrezaei (Dr., Isfahan University of Medical Sciences) — Principal investigator
First posted
Sep 24, 2013
Start date
Sep 2011
Primary completion
Oct 2012
Completion
Jan 2013
Last update
Oct 18, 2013

Study contacts

Ahmad Shavakhi, M.D.
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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