Clinical trial NCT01949038: Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy
Official title: Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diagnostic Esophagogastroduodenoscopy
Keywords: Pain
Discomfort
Anxiety
Satisfaction
Compliance
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-09-24
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Procedure related pain/discomfort
timeFrame: Within the first one hour after the procedure
Secondary outcomes:
measure: Pre-procedure anxiety
timeFrame: Before and 30 minutes after medication
measure: Patients' satisfaction
timeFrame: Within the first one hour after the procedure
measure: Compliance
timeFrame: Within the first one hour after the procedure
measure: Duration of the procedure
timeFrame: Within the first one hour after the procedure
measure: Side effects
timeFrame: Within the first one hour after the procedure
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Private Outpatient Clinic of Gastroenterology
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Ahmad Shavakhi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.