Diagnostic Esophagogastroduodenoscopy
Conditions
Keywords
Pain, Discomfort, Anxiety, Satisfaction, Compliance
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.
Interventions
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure related pain/discomfort | Within the first one hour after the procedure | Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-procedure anxiety | Before and 30 minutes after medication | Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication. |
| Patients' satisfaction | Within the first one hour after the procedure | Procedure related patients' satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure. |
| Compliance | Within the first one hour after the procedure | Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure. |
| Duration of the procedure | Within the first one hour after the procedure | Duration of the procedure is recorded. |
| Side effects | Within the first one hour after the procedure | Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure. |
Countries
Iran
Outcome results
None listed