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

DongGuk University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Sedation Endoscopy

Interventions

PropofolDRUG

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

MidazolamDRUG

midazolam with propofol

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

The prevalence of paradoxical response

The proportion of participants who show paradoxical response during endoscopy

Time frame: At the end of endoscopy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.