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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
136
Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
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.
Department of Gastroenterology, Alzahra Hospital
Isfahan, Iran
Discomfort assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake
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.
Time frame: 5 minutes after the procedure
Change in anxiety
Procedure related anxiety is assessed by patients on a 11-point numeric rating scales at baseline and then at 30 minutes after the medication.
Time frame: At baseline and at 30 minutes after medication
Satisfaction is assessed by patients on a 11-point numeric rating scales about 5 minutes after the procedure when patients are fully awake.
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.
Time frame: 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.
Tolerance is assessed by patients from no compliance (0) to excellent compliance (4) about 5 minutes after the procedure when patients are fully awake.
Time frame: 5 minutes after the procedure
Duration of the procedure
Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.
Time frame: From endoscope insertion to endoscope removal
Hypotension
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
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Bradycardia
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.
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Desaturation
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%.
Time frame: At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
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