Effectiveness, safety, and pharmacokinetic and pharmacodynamic characteristics of microemulsion propofol in patients undergoing elective surgery under.

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Presentation transcript:

Effectiveness, safety, and pharmacokinetic and pharmacodynamic characteristics of microemulsion propofol in patients undergoing elective surgery under total intravenous anaesthesia‡ J.A. Jung, B.M. Choi, S.H. Cho, S.M. Choe, J.L. Ghim, H.M. Lee, Y.J. Roh, G.J. Noh British Journal of Anaesthesia Volume 104, Issue 5, Pages 563-576 (May 2010) DOI: 10.1093/bja/aeq040 Copyright © 2010 The Author(s) Terms and Conditions

Fig 1 Enrolment, group assignment, and analysis. In total, 288 patients were included in the safety and intention-to-treat analyses (n=144 in the microemulsion group, 144 in the LCT group). Of these patients, four were excluded from TimeLOC and BISLOC analyses because they were too deeply sedated before the administration of investigational drugs, owing to premedication with midazolam. Therefore, 284 patients were included in TimeLOC, TimeROC, TimeROO, BISLOC, BISROC, and BISROO analyses (n=143 in the microemulsion group, 141 in the LCT group). TimeLOC, time to loss of consciousness after an i.v. bolus of propofol 2 mg kg−1; TimeROC, time to recovery of consciousness after infusion of each propofol formulation was terminated; TimeROO, time to recovery of orientation after extubation; BISLOC, ROC, ROO, bispectral index values at LOC, ROC, and ROO. British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions

Fig 2 Differences in times to (a) LOC, (b) ROC, and (c) recovery of orientation between male and female patients in the microemulsion and LCT groups. The central box covers the inter-quartile range with the median indicated by the line within the box. The whiskers extend to the 10th percentile and 90th percentile values. More extreme values (filled circle) are plotted individually. Data are expressed as median (25–75%). TimeLOC between male and female in microemulsion were 23.0 (16.0–31.0) and 18.0 (12.0–26.0) s, respectively. TimeROC and TimeROO between male and female in microemulsion were 13.9 (9.1–20.6), 10.8 (7.7–15.2), 2.2 (1.0–5.3), 1.3 (0.7–2.9) min, respectively. TimeLOC, TimeROC, and TimeROO between male and female in LCT were 20.0 (14.0–24.3), 16.0 (10.3–22.0) s, 11.7 (8.8–17.9), 9.0 (5.4–12.0), 1.9 (1.4–3.6), 1.2 (0.7–2.5) min, respectively. *P<0.05 vs female (Mann–Whitney rank-sum test). British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions

Fig 3 The distribution of VAS scores for pain on injection with microemulsion and LCT propofol after a 30 mg test dose of propofol. The median VAS scores (25–75%) for pain on injection of microemulsion and LCT propofol were 72.0 (40.0–92.0) and 11.5 (0.0–39.8) mm, respectively (P<0.001, Mann–Whitney rank-sum test). The solid horizontal lines represent median VAS scores. British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions

Fig 4 Cumulative propofol dose at each sampling point during infusion of microemulsion and LCT and the plasma concentrations of propofol over time. *P<0.05 vs long LCT propofol. (a) Cumulative propofol dose at 10, 30, and 60 min after the start of propofol formulation infusion and at the end of infusion. (b) Plasma propofol concentrations at LOC, 10, 30, and 60 min after the start of propofol formulation infusion. (c) Plasma propofol concentrations at 0, 1, 6, 12, and 24 h after each propofol formulation was discontinued. British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions

Fig 5 Predictive checks of the final pharmacokinetic models and the CWRES vs predicted propofol concentrations. (a) Predictive check for microemulsion propofol. (b) CWRES vs predicted propofol concentration for microemulsion propofol. (c) Predictive check for LCT propofol. (d) CWRES vs predicted LCT propofol concentration. Less than 10% of the data distributed outside the 90% prediction intervals (5.94% for microemulsion propofol and 5.47% for LCT propofol), indicating that the final pharmacokinetic models for both formulations adequately describe the time-courses of propofol plasma concentrations. Grey area between solid lines: 90% prediction intervals. British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions

Fig 6 Predictive checks of the final pharmacodynamic models and CWRES vs predicted BIS. (a) Predictive check for microemulsion propofol. (b) CWRES vs predicted BIS for microemulsion propofol. (c) Predictive check for LCT propofol. (d) CWRES vs predicted BIS for LCT propofol. Less than 10% of the data distributed outside the 90% prediction intervals, indicating that the final pharmacodynamic models (3.0% for microemulsion propofol and 2.4% for LCT propofol) for both formulations adequately describe the time-courses of BIS. Empty area between grey horizontal marks (−): 90% prediction intervals. British Journal of Anaesthesia 2010 104, 563-576DOI: (10.1093/bja/aeq040) Copyright © 2010 The Author(s) Terms and Conditions