NCT01949038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
Last Updated

October 18, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

September 17, 2013

Last Update Submit

October 16, 2013

Conditions

Diagnostic Esophagogastroduodenoscopy

Keywords

PainDiscomfortAnxietySatisfactionCompliance

Outcome Measures

Primary Outcomes (1)

  • Procedure related pain/discomfort

    Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure.

    Within the first one hour after the procedure

Secondary Outcomes (5)

  • Pre-procedure anxiety

    Before and 30 minutes after medication

  • Patients' satisfaction

    Within the first one hour after the procedure

  • Compliance

    Within the first one hour after the procedure

  • Duration of the procedure

    Within the first one hour after the procedure

  • Side effects

    Within the first one hour after the procedure

Study Arms (4)

Oral placebo

PLACEBO COMPARATOR

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

Drug: Oral placebo

Sublingual placebo

PLACEBO COMPARATOR

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

Drug: Sublingual placebo

Sublingual alprazolam

ACTIVE COMPARATOR

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

Drug: Sublingual alprazolam

Oral alprazolam

ACTIVE COMPARATOR

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

Drug: Oral alprazolam

Interventions

Oral alprazolamDRUG
Oral alprazolam
Sublingual alprazolamDRUG
Sublingual alprazolam
Oral placeboDRUG
Oral placebo
Sublingual placeboDRUG
Sublingual placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Outpatient Clinic of Gastroenterology

Isfahan, Isfahan, Iran

Location

Related Publications (2)

  • 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.

    PMID: 2009843BACKGROUND

  • 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.

    PMID: 24977401DERIVED

MeSH Terms

Conditions

PainAnxiety DisordersPersonal SatisfactionPatient Compliance

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ahmad Shavakhi, M.D.

    Isfahan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 24, 2013

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

October 18, 2013

Record last verified: 2013-10

Locations

IR(1)