Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

Phase 4

• Conditions: Conscious Sedation Failure During Procedure
• Interventions: Drug: Oral midazolam

• Registration Number: NCT01990937
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?

Detailed Description

Five mg of midazolam was intake orally about 30 minutes before undergoing perform upper gastrointestinal endoscopy. Declined of anxiety scores was primary end point.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-20
• Study First Submitted QC: 2013-11-16
• Study First Posted: 2013-11-25
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-29
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Scheduled to undergo elective diagnostic EGD
• American Society of Anesthesia (ASA) criteria to be class 1 to 2

Exclusion Criteria

• History of gastrectomy, esophagectomy, pancreaticoduodenectomy, or other operation on the upper-GI tract
• American Society of Anesthesia (ASA) criteria to be class 3 to 4
• Pregnancy
• Alcoholism
• Drug abuse
• Taking psychotic medications
• Allergy to midazolam.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral midazolam	Oral midazolam	Oral midazolam (5 mg) in 15 mL of apple juice was drunk 30 minutes before EGD

Primary Outcome Measures

Name	Time	Method
Difference of Anxiety score	Asked the patient 5 minutes before EGD and then after fully recovery from sedation.	* Anxiety score is 10-cm scaled visual analog scale.; * Anxiety score which asked the patient 5 minutes before EGD, called "Pre EGD anxiety score"; * Anxiety score which asked the patient after fully recovery, called "During EGD anxiety score".; * Difference of anxiety score means "Pre EGD minus During anxiety score".; * Fully recovery means fully gain of consiouness (time, place, person).

Secondary Outcome Measures

Name	Time	Method
Overall tolerance	Asked the patient after fully recovery from sedation.	Fully recovery means fully gain of consiouness (time, place, person).; Overall tolerance was grading into 4 levels; * Poor : Very uncomfortable during the entire procedure; * Fair : Uncomfortable during most of the procedure; * Good : Believes the procedure was generally comfortable, there were portions of procedure during which sedation could have been given; * Excellent : Believes the procedure was comfortable, no additional sedation was needed

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital; 🇹🇭 Bangkok, Thailand