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doi: 10.1097/01.anes.0000435741.97234.04
Perioperative Medicine: Clinical Science

Comparison of the Potency of Different Propofol Formulations: A Randomized, Double-blind Trial Using Closed-loop Administration

Le Guen, Morgan M.D.; Grassin-Delyle, Stanislas Ph.D.; Cornet, Camille M.D.; Genty, Antoine M.D.; Chazot, Thierry M.D.; Dardelle, Dominique Pharm.D.; Liu, Ngai M.D., Ph.D.; Dreyfus, Jean-François M.D., Ph.D.; Mazoit, Jean-Xavier M.D., Ph.D.; Devillier, Philippe M.D., Ph.D.; Alvarez, Jean-Claude Ph.D.; Sessler, Daniel I. M.D.; Fischler, Marc M.D.



In the February 2014 issue, the propofol formulations named and discussed in this article are in error. Propoven®, which was used in the United States during a propofol shortage (see Jensen V, Rappaport BA: The reality of drug shortages—the case of the injectable agent propofol. N Engl J Med 2010;363:806–7),was presented as one of the drugs studied, whereas a different formation from the same manufacturer, Propofol® (Fresenius), was in fact studied. Propofol®, which is marketed worldwide but has never been used in the United States, contains only long-chain triglycerides. In contrast, Propoven® is formulated with a mixture of long- and medium-chain triglycerides.
The term Propofol® should replace Propoven® throughout the paper, except in the first paragraph of the introduction.
The comparison among the three formulations provides useful information in countries where all three are available. However, due to this error, the implications that a formulation marketed in the United States during the propofol shortage was studied are false, since they refer to a formulation which was not studied.
The authors contacted the journal with this information and regret the error.

Anesthesiology. 121(3):672, September 2014.

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Background: Several commercial formulations of propofol are available. The primary outcome of this study was the required dose of propofol alone or combined with lidocaine to achieve induction of general anesthesia.
Methods: This multicenter, double-blinded trial randomized patients (American Society of Anesthesiologists physical status I–III) just before elective surgery with the use of a computer-generated list. Three different propofol 1% formulations—Diprivan® (Astra-Zeneca, Cheshire, United Kingdom), Propoven® (Fresenius-Kabi AG, Bad Homburg, Germany), and Lipuro® (B-Braun, Melshungen AG, Germany)—were compared with either placebo (saline solution) or lidocaine 1% mixed to the propofol solution. Depth of anesthesia was automatically guided by bispectral index and by a computerized closed-loop system for induction, thus avoiding dosing bias. The authors recorded the total dose of propofol and duration of induction and the patient’s discomfort through a behavioral scale (facial expression, verbal response, and arm withdrawal) ranging from 0 to 6. The authors further evaluated postoperative recall of pain using a Visual Analog Scale.
Results: Of the 227 patients enrolled, 217 were available for analysis. Demographic characteristics were similar in each group. Propoven® required a higher dose for induction (2.2 ± 0.1 mg/kg) than Diprivan® (1.8 ± 0.1 mg/kg) or Lipuro® (1.7 ± 0.1 mg/kg; P = 0.02). However, induction doses were similar when propofol formulations were mixed with lidocaine. Patient discomfort during injection was significantly reduced with lidocaine for every formulation: Diprivan® (0.5 ± 0.3 vs. 2.3 ± 0.3), Propoven® (0.4 ± 0.3 vs. 2.4 ± 0.3), and Lipuro® (1.1 ± 0.3 vs. 1.4 ± 0.3), all differences significant, with P < 0.0001. No adverse effect was reported.
Conclusion: Plain propofol formulations are not equipotent, but comparable doses were required when lidocaine was concomitantly administered.

© 2014 American Society of Anesthesiologists, Inc.

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