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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol alone | Experimental | Participants who receive propofol alone during sedative endoscopy. |
|
| Midazolam with propofol | Active Comparator | Participants who receive midazolam + propofol during sedative endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of paradoxical response | The proportion of participants who show paradoxical response during endoscopy | At the end of endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 10326 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22615018 | Background | 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. | |
| 24893689 | Result |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Midazolam | Drug | midazolam with propofol |
|
| 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. |
| 15460178 | Result | 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. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |