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CompletedNCT04072328Updated Dec 29, 2020

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

A Phase 2 interventional study of Propofol and Midazolam in Sedation and Endoscopy, sponsored by DongGuk University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-12-29.

Sponsored by DongGuk University · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

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.

02

Conditions studied

  • Sedation
  • Endoscopy

Keywords

  • Midazolam
  • Propofol
  • Sedation
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of midazolam-induced paradoxical response

Exclusion criteria

Exclusion Criteria:

  • Failed to obtain informed consent
  • Pregnant or breast feeding women
  • A severe cardiopulmonary or vascular disease with symptoms
  • Cognitive or mental impairment
04

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Propofol alone

    Participants who receive propofol alone during sedative endoscopy.

    Drug: Propofol

  • Active comparator
    Midazolam with propofol

    Participants who receive midazolam + propofol during sedative endoscopy.

    Drug: Propofol · Drug: Midazolam

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

05

What researchers measure

Primary outcomes

  1. The prevalence of paradoxical response

    The proportion of participants who show paradoxical response during endoscopy

    Time frame: At the end of endoscopy

06

Study locations

1 site
  • Dongguk University Ilsan Hospital
    Goyang-si, Gyeonggi-do 10326, Korea, Republic of
07

References and documents

Publications

  • Lee TH, Lee CK, Park SH, Lee SH, Chung IK, Choi HJ, Cha SW, Moon JH, Cho YD, Hwangbo Y, Kim SJ. Balanced propofol sedation versus propofol monosedation in therapeutic pancreaticobiliary endoscopic procedures. Dig Dis Sci. 2012 Aug;57(8):2113-21. doi: 10.1007/s10620-012-2234-0. Epub 2012 May 22. PubMed 22615018 ↗
  • Tae CH, Kang KJ, Min BH, Ahn JH, Kim S, Lee JH, Rhee PL, Kim JJ. Paradoxical reaction to midazolam in patients undergoing endoscopy under sedation: Incidence, risk factors and the effect of flumazenil. Dig Liver Dis. 2014 Aug;46(8):710-5. doi: 10.1016/j.dld.2014.04.007. Epub 2014 Jun 2. PubMed 24893689 ↗
  • Mancuso CE, Tanzi MG, Gabay M. Paradoxical reactions to benzodiazepines: literature review and treatment options. Pharmacotherapy. 2004 Sep;24(9):1177-85. doi: 10.1592/phco.24.13.1177.38089. PubMed 15460178 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04072328
Lead sponsor
DongGuk University
Responsible party
Dong Kee Jang (Assistant Professor, DongGuk University) — Principal investigator
First posted
Aug 28, 2019
Start date
Oct 19, 2018
Primary completion
Aug 10, 2020
Completion
Dec 20, 2020
Last update
Dec 29, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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