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Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

I

Isfahan University of Medical Sciences

Status and phase

Completed
Phase 3
Phase 2

Conditions

Diagnostic Esophagogastroduodenoscopy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

220 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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