Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Diagnostic Esophagogastroduodenoscopy Clinical Trial

Official title:

Comparing Efficacy of Oral Midazolam and Sublingual Alprazolam in Reducing Anxiety and Pain/Discomfort Related to Diagnostic Upper Gastrointestinal Endoscopy in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130842
• Other study ID #: 395569
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 3, 2017
• Last updated: April 23, 2017
• Start date: September 17, 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: April 2017
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Esophagogastroduodenoscopy

Intervention

Drug:
• Sublingual alprazolam
Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
• Oral 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Gastroenterology, Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 minutes after the procedure
Primary	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.	At baseline and at 30 minutes after medication
Secondary	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.	5 minutes after the procedure
Secondary	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.	5 minutes after the procedure
Secondary	Duration of the procedure	Duration of the procedure is defined as time (minute) from endoscope insertion to endoscope removal.	From endoscope insertion to endoscope removal
Secondary	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	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Secondary	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.	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.
Secondary	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%.	At baseline, 30 minutes after medication, at the beginning of procedure, and then every 5 minutes for 30 minutes.