Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

December 28, 2020 updated by: Dong Kee Jang, DongGuk University
This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10326
        • DongGuk University ilsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of midazolam-induced paradoxical response

Exclusion Criteria:

  • Failed to obtain informed consent
  • Pregnant or breast feeding women
  • A severe cardiopulmonary or vascular disease with symptoms
  • Cognitive or mental impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol alone
Participants who receive propofol alone during sedative endoscopy.
Drug: Propofol
Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
Active Comparator: Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
Drug: Propofol
Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
Drug: Midazolam
midazolam with propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of paradoxical response
Time Frame: At the end of endoscopy
The proportion of participants who show paradoxical response during endoscopy
At the end of endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

August 10, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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