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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04072328

Enrollment

Registered

2019-08-28

Start date

2018-10-19

Completion date

2020-12-20

Last updated

2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy, Sedation

Keywords

Midazolam, Propofol, Sedation

Brief summary

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.

Interventions

DRUGPropofol

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

DRUGMidazolam

midazolam with propofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026