Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

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

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

Study Overview

• Status: Unknown
• Conditions: Conscious Sedation Failure During Procedure
• Intervention / Treatment: Drug: Oral midazolam

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 Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chaipichit Puttapitakpong, Doctor; Phone Number: 6681707-3005; Email: iamkeang@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital
    • Contact: Chaipichit Puttapitakpong, Doctor; Phone Number: 6681707-3005; Email: iamkeang@hotmail.com
    • Principal Investigator: Chaipichit Puttapitakpong, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amnesia score	Fully recovery means fully gain of consiouness (time, place, person). Amnesia score was grading into 4 levels; = Patient unable to recall any portion of procedure; = Able to recall and describe some portion of procedure; = Able to recall and describe most of procedure; = Able to recall and describe entire procedure	Asked the patient after fully recovery from sedation.
Overall satisfaction	Fully recovery means fully gain of consiouness (time, place, person). Overall satifaction was 10-cm scaled visual analog scale.	Asked the patient after fully recovery from sedation.
Willing to repeat EGD	Fully recovery means fully gain of consiouness (time, place, person). Willing to repeat EGD was defined to "Yes or No".	Asked the patient after fully recovery from sedation.
Vital signs	Vital signs were blood pressure(mmHg), heart rates(beats per minute), respiratory rates(per minute) and oxygen saturation(percents).	Vital signs were measured at 5 minutes before EGD then measured every 5 minutes during EGD until the patient was fully recovery after the EGD was finished.

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital
• Investigators: Principal Investigator: Chaipichit Puttapitakpong, Doctor, Division of gastroentrology, Department of Medicine, Phramongkutklao hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): February 1, 2015

Study Registration Dates

• First Submitted: October 20, 2013
• First Submitted That Met QC Criteria: November 16, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: EGD; sedation; premedication; upper gastrointestinal endoscopy; oral midazolam
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: PMK-031