Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

Study Overview
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Brief Summary
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Can oral midazolam used for sedation in patients undergoing upper gastrointestinal endoscopy ?

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

Official Title
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Effectiveness of Oral Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy

Conditions
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Conscious Sedation Failure During Procedure

Intervention / Treatment
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* Drug: Oral midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral midazolam<br>Oral midazolam (5 mg) in 15 mL of apple juice was drunk 30 minutes before EGD | Drug: Oral midazolam<br>* 5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD<br>* Other names: Dormicum;|
| Placebo Comparator: Apple juice<br>15 mL of apple juice was drunk 30 minutes before EGD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Anxiety score | 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). | Asked the patient 5 minutes before EGD and then after fully recovery from sedation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall tolerance | 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 | Asked the patient after fully recovery from sedation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral midazolam, sedation, premedication, upper gastrointestinal endoscopy, EGD