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Title: | Effects of intravenous bolus injection of emulsified isoflurane on QTc interval of healthy volunteers in Pharmacokinetics study |
Authors: | Rong Liu Yan Li Jin Liu Zhang, Wen-Sheng Yi, Xiao-Qian Jing XU |
Keywords: | Emulsified isoflurane QTc interval prolongation novel anesthetic |
Issue Date: | 20-Sep-2014 |
Publisher: | Karachi:Pakistan Journal of Pharmaceutical Sciences, university of Karachi. |
Citation: | Liu, R., Li, Y., Liu, J., Zhang, W. S., Yi, X. Q., & Jing, X. U. (2014). Effects of intravenous bolus injection of emulsified isoflurane on QTc interval of healthy volunteers in Pharmacokinetics study. Pakistan Journal of Pharmaceutical Sciences, 27(5). |
Abstract: | Emulsified isoflurane is a novel intravenous anesthetic, which is a lipid emulsion of isoflurane. As some drugs have a QTc-prolongation effect which can increase a risk of arrhythmia, this study was to evaluate the effects of emulsified isoflurane on the QTc interval. This was a single-center, randomized, single-blind, non-comparative study. Subjects were randomly allocated to receive an intravenous bolus injection of 22.63, 38.26, or 49.73 mg/kg emulsified isoflurane, respectively. Standard 12-lead electrocardiograms were recorded before administration and at 28 timepoints after administration. Blood samples and the end-tidal isoflurane concentrations were collected for pharmacokinetic analysis. The primary target variable was the QTcF change from baseline at each time point. A two-sided 90% confidence interval (CI) was calculated for a QTcF change from baseline at each timepoint. The maximal 90% CIs of the mean QTcF from the baseline for 22.63, 38.26 and 49.73mg/kg emulsified isoflurane were 2.52-21.18 ms, 15.66-35.90 ms, and 17.65-40.71 ms, respectively. Non-significant relationship was observed between QTcF and the plasma concentration (or the end-tidal isoflurane concentration). Single intravenous dose of emulsified isoflurane of the anticipated therapeutic dose or supra-therapeutic doses was associated with a potential dose-dependent and nonconcentration-related QTc-prolongation effect. |
URI: | http://142.54.178.187:9060/xmlui/handle/123456789/16493 |
ISSN: | 1011-601X |
Appears in Collections: | Issue No.5 |
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