MedTrace Logo

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

NCT04072328 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-12-29

No results posted yet for this study

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.

Conditions

  • Sedation
  • Endoscopy

Interventions

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

Sponsors & Collaborators

  • DongGuk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-19
Primary Completion
2020-08-10
Completion
2020-12-20

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072328 on ClinicalTrials.gov