Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Diagnostic Esophagogastroduodenoscopy Clinical Trial

Official title:

Comparison Between Sublingual and Oral Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949038
• Other study ID #: 391009
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 17, 2013
• Last updated: October 16, 2013
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diagnostic Esophagogastroduodenoscopy

Intervention

Drug:
• Oral alprazolam

• Sublingual alprazolam

• Oral placebo

• Sublingual placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Private Outpatient Clinic of Gastroenterology	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Hedenbro JL, Ekelund M, Aberg T, Lindblom A. Oral sedation for diagnostic upper endoscopy. Endoscopy. 1991 Jan;23(1):8-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure related pain/discomfort	Procedure related pain/discomfort is assessed by patients on a 11-point numeric rating scales after the procedure.	Within the first one hour after the procedure	No
Secondary	Pre-procedure anxiety	Procedure related anxiety is assessed by patients on a 11-point numeric rating scales before and 30 minutes after the medication.	Before and 30 minutes after medication	No
Secondary	Patients' satisfaction	Procedure related patients' satisfaction is assessed by patients on a 11-point numeric rating scales after the procedure.	Within the first one hour after the procedure	No
Secondary	Compliance	Compliance is assessed by patients from no compliance (0) to excellent compliance (4) after the procedure.	Within the first one hour after the procedure	No
Secondary	Duration of the procedure	Duration of the procedure is recorded.	Within the first one hour after the procedure	No
Secondary	Side effects	Any side effects attributed to alprazolam is assessed Within the first one hour after the procedure.	Within the first one hour after the procedure	Yes