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The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palonosetron | Experimental | Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia |
|
| Control | Placebo Comparator | Intravenous administration of normal saline before the induction of general anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron | Drug | 0.075 mg IV as bolus before induction of general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| corrected QT interval (QTc interval) | at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation | up to 90 minutes after induction of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female | up to 2 hours after induction of general anesthesia | |
| corrected QT interval (QTc interval) at Postanesthetic care unit | up to 1 hour after arrival on postanesthetic care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24129597 | Derived | Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14. |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
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| Normal saline | Drug | 2 ml normal saline as bolus before induction of general anesthesia |
|
| Incidence of postoperative nausea and vomiting | for 24 hours after surgery |
| proportion of patients who have more than 500 ms of corrected QT interval (QTc interval) | up to 2 hours after induction of general anesthesia |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |