Diagnostic Esophagogastroduodenoscopy
Conditions
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.
Interventions
Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
DRUGOral midazolam
Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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 |
|---|---|---|
| Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake | 5 minutes after the procedure | Procedure related discomfort is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. |
| Change in anxiety | At baseline and at 30 minutes after medication | Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake. | 5 minutes after the procedure | Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake. |
| Duration of the procedure | From endoscope insertion to endoscope removal | Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal. |
| Bradycardia | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. | Heart rate is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Bradycardia episode is defined as heart rate of \< 60 bpm. |
| Desaturation | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. | Arterial O2 saturation is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Desaturation episode is defined as as arterial oxygen saturation of \< 90%. |
| Hypotension | At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes. | Blood pressure is monitored from baseline to 30 minutes after beginning of the procedure, with 5 minutes intervals. Hypotension episode is defined as systolic blood pressure of \< 90 mm Hg |
| Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. | 5 minutes after the procedure | Procedure related satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake. |
Countries
Iran
Outcome results
None listed