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Clinical Trials/NCT01990937
NCT01990937
Unknown
Phase 4

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

Phramongkutklao College of Medicine and Hospital1 site in 1 country260 target enrollmentOctober 2013

Overview

Phase
Phase 4
Intervention
Oral midazolam
Conditions
Conscious Sedation Failure During Procedure
Sponsor
Phramongkutklao College of Medicine and Hospital
Enrollment
260
Locations
1
Primary Endpoint
Difference of Anxiety score
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Phramongkutklao College of Medicine and Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Oral midazolam

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

Intervention: Oral midazolam

Outcomes

Primary Outcomes

Difference of Anxiety score

Time Frame: 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 Outcomes

  • Overall tolerance(Asked the patient after fully recovery from sedation.)

Study Sites (1)

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