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Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

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ClinicalTrials.gov Identifier: NCT01949038
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : October 18, 2013
Sponsor:
Information provided by (Responsible Party):
Ali Gholamrezaei, Isfahan University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Diagnostic Esophagogastroduodenoscopy Drug: Oral alprazolam Drug: Sublingual alprazolam Drug: Oral placebo Drug: Sublingual placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Endoscopy
Drug Information available for: Alprazolam

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949038


Locations
Iran, Islamic Republic of
Private Outpatient Clinic of Gastroenterology
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Ahmad Shavakhi, M.D. Isfahan University of Medical Sciences

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ali Gholamrezaei, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01949038     History of Changes
Other Study ID Numbers: 391009
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: October 18, 2013
Last Verified: October 2013

Keywords provided by Ali Gholamrezaei, Isfahan University of Medical Sciences:
Pain
Discomfort
Anxiety
Satisfaction
Compliance

Additional relevant MeSH terms:
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action