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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 10, 2020

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

Arms, Groups and Cohorts

  • Experimental: Propofol alone
    • Participants who receive propofol alone during sedative endoscopy.
  • Active Comparator: Midazolam with propofol
    • Participants who receive midazolam + propofol during sedative endoscopy.

Clinical Trial Outcome Measures

Primary Measures

  • The prevalence of paradoxical response
    • Time Frame: At the end of endoscopy
    • The proportion of participants who show paradoxical response during endoscopy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • DongGuk University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dong Kee Jang, Assistant Professor – DongGuk University

References

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.

Citations Reporting on Results

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.

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.

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