Oral Midazolam for Sedation in Esophagogastroduodenoscopy(EGD)

Conscious Sedation Failure During Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01990937
• Other study ID #: PMK-031
• Status: Recruiting
• Phase: Phase 4
• First received: October 20, 2013
• Last updated: October 27, 2014
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: October 2014
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: Chaipichit Puttapitakpong, Doctor
• Phone: 6681707-3005
• Email: iamkeang[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conscious Sedation Failure During Procedure

Intervention

Drug:
• Oral midazolam
5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD

Locations

Country	Name	City	State
Thailand	Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Other	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.	No
Other	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.	No
Other	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.	Yes
Primary	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.	No
Secondary	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.	No