Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
NCT ID: NCT04072328
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2018-10-19
2020-12-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Propofol alone
Participants who receive propofol alone during sedative endoscopy.
Propofol
Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnant or breast feeding women
* A severe cardiopulmonary or vascular disease with symptoms
* Cognitive or mental impairment
19 Years
ALL
No
Sponsors
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DongGuk University
OTHER
Responsible Party
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Dong Kee Jang
Assistant Professor
Locations
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Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, South Korea
Countries
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References
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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.
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.
Other Identifiers
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2018-02-011
Identifier Type: -
Identifier Source: org_study_id