Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Phase 2

Completed

• Conditions: Diagnostic Esophagogastroduodenoscopy
• Interventions: Drug: Sublingual alprazolam; Drug: Oral midazolam

• Registration Number: NCT03130842
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-17
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-15
• Status Verified: 2017-04
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-23
• Last Update Submitted: 2017-04-23
• Study First Posted: 2017-04-27
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual alprazolam	Sublingual alprazolam	-
Oral midazolam	Oral midazolam	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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%.
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.
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.
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
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.

Trial Locations

Locations (1)

Department of Gastroenterology, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of