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NCT04072328 Clinical Trial

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

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04072328
Other study ID # 2018-02-011
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 19, 2018
Est. completion date December 20, 2020

Study information
Verified date December 2020
Source DongGuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 20, 2020
Est. primary completion date August 10, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
• Midazolam
midazolam with propofol

Locations
Country Name City State
Korea, Republic of Dongguk University Ilsan Hospital Goyang-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Mancuso CE, Tanzi MG, Gabay M. Paradoxical reactions to benzodiazepines: literature review and treatment options. Pharmacotherapy. 2004 Sep;24(9):1177-85. Review. — View Citation

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.d — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The prevalence of paradoxical response The proportion of participants who show paradoxical response during endoscopy At the end of endoscopy
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