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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedation Endoscopy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.

midazolam

Drug

midazolam with propofol

Primary outcomes

The prevalence of paradoxical response

Time frame: At the end of endoscopy

The proportion of participants who show paradoxical response during endoscopy

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Aug 28, 2019
Registry last updated: Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed