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OpenTrials
Completed

NCT Number: NCT01949038

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.

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Key information

Conditions

Diagnostic Esophagogastroduodenoscopy Anxiety Disorders Behavior Health Behavior Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Personal Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Private Outpatient Clinic of Gastroenterology

Isfahan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral alprazolam

Drug

Sublingual alprazolam

Drug

oral placebo

Drug

Sublingual Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Duration of the procedure

    Time frame: Within the first one hour after the procedure

    Duration of the procedure is recorded.

  5. 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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 24, 2013
Registry last updated
Oct 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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