Clinical trial NCT03130842: Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy
Official title: Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diagnostic Esophagogastroduodenoscopy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diagnostic upper GI endoscopy can be uncomfortable and stressful for many 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. Intravenous midazolam is being used by some centers for sedation during endoscopy, but the oral form can also be used with probably same efficacy. Hence, investigators compare the efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral midazolam 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: Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
timeFrame: 5 minutes after the procedure
measure: Change in anxiety
timeFrame: At baseline and at 30 minutes after medication
Secondary outcomes:
measure: Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
timeFrame: 5 minutes after the procedure
measure: Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.
timeFrame: 5 minutes after the procedure
measure: Duration of the procedure
timeFrame: From endoscope insertion to endoscope removal
measure: Hypotension
timeFrame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
measure: Bradycardia
timeFrame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
measure: Desaturation
timeFrame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Department of Gastroenterology, Alzahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Vahid Sebghatolahi, MD
role: STUDY_DIRECTOR
References:
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.