Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Overview

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.

Full Title of Study: “Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: October 2012

Interventions

  • Drug: Oral alprazolam
  • Drug: Sublingual alprazolam
  • Drug: Oral placebo
  • Drug: Sublingual placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Oral placebo
    • Patients receive one oral dose of placebo least 30 minutes before the procedure.
  • Placebo Comparator: Sublingual placebo
    • Patients receive one oral dose of placebo at least 30 minutes before the procedure.
  • Active Comparator: Sublingual alprazolam
    • Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.
  • Active Comparator: Oral alprazolam
    • Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Pre-procedure anxiety
    • Time Frame: Before and 30 minutes after medication
    • Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication.
  • Patients’ satisfaction
    • Time Frame: Within the first one hour after the procedure
    • Procedure related patients’ satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure.
  • Compliance
    • Time Frame: Within the first one hour after the procedure
    • Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure.
  • Duration of the procedure
    • Time Frame: Within the first one hour after the procedure
    • Duration of the procedure is recorded.
  • Side effects
    • Time Frame: Within the first one hour after the procedure
    • Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Isfahan University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Gholamrezaei, Dr. – Isfahan University of Medical Sciences
  • Overall Official(s)
    • Ahmad Shavakhi, M.D., Principal Investigator, Isfahan University of Medical Sciences

References

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.

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