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Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

NCT ID: NCT01949038

Last Updated: 2013-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diagnostic Esophagogastroduodenoscopy

Keywords

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Pain Discomfort Anxiety Satisfaction Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Oral placebo

Patients receive one oral dose of placebo least 30 minutes before the procedure.

Group Type PLACEBO_COMPARATOR

Oral placebo

Intervention Type DRUG

Sublingual placebo

Patients receive one oral dose of placebo at least 30 minutes before the procedure.

Group Type PLACEBO_COMPARATOR

Sublingual placebo

Intervention Type DRUG

Sublingual alprazolam

Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Group Type ACTIVE_COMPARATOR

Sublingual alprazolam

Intervention Type DRUG

Oral alprazolam

Patients receive one oral dose of alprazolam 0.5 mg at least 30 minutes before the procedure.

Group Type ACTIVE_COMPARATOR

Oral alprazolam

Intervention Type DRUG

Interventions

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Oral alprazolam

Intervention Type DRUG

Sublingual alprazolam

Intervention Type DRUG

Oral placebo

Intervention Type DRUG

Sublingual placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ali Gholamrezaei

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Shavakhi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

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Private Outpatient Clinic of Gastroenterology

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type BACKGROUND
PMID: 2009843 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24977401 (View on PubMed)

Other Identifiers

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391009

Identifier Type: -

Identifier Source: org_study_id