NCT01990937

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.2 years

First QC Date

October 20, 2013

Last Update Submit

October 27, 2014

Conditions

Conscious Sedation Failure During Procedure

Keywords

oral midazolamsedationpremedicationupper gastrointestinal endoscopyEGD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall tolerance

    Asked the patient after fully recovery from sedation.

Other Outcomes (4)

  • Amnesia score

    Asked the patient after fully recovery from sedation.

  • Overall satisfaction

    Asked the patient after fully recovery from sedation.

  • Willing to repeat EGD

    Asked the patient after fully recovery from sedation.

  • +1 more other outcomes

Study Arms (2)

Oral midazolam

ACTIVE COMPARATOR

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

Drug: Oral midazolam

Apple juice

PLACEBO COMPARATOR

15 mL of apple juice was drunk 30 minutes before EGD

Interventions

Oral midazolamDRUG

5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD

Also known as: Dormicum
Oral midazolam

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled to undergo elective diagnostic EGD
  • American Society of Anesthesia (ASA) criteria to be class 1 to 2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, Department of Medicine, Phramongkutklao hospital

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chaipichit Puttapitakpong, Doctor

    Division of gastroentrology, Department of Medicine, Phramongkutklao hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chaipichit Puttapitakpong, Doctor

CONTACT

6681707-3005iamkeang@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2013

First Posted

November 25, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

TH(1)