Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

Phramongkutklao College of Medicine and Hospital

Status and phase: Unknown; Phase 4

Conditions: Conscious Sedation Failure During Procedure

Treatments: Drug: Oral midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01990937

PMK-031

Details and patient eligibility

About

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

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups, including a placebo group

Oral midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Oral midazolam

Apple juice

Placebo Comparator group

Description:

15 mL of apple juice was drunk 30 minutes before EGD