Comparison of the potency of different propofol formulations: a randomized, double-blind trial using closed-loop administration.
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.


CONCLUSIONS
Plain propofol formulations are not equipotent, but comparable doses were required when lidocaine was concomitantly administered.
From the Department of Anesthesiology, Hôpital Foch, University Versailles Saint-Quentin en Yvelines, Suresnes, France (M.L.G., C.C, T.C.); Laboratory of Pharmacology and Toxicology, Hôpital Raymond Poincaré, University Versailles Saint-Quentin en Yvelines, Garches, France, and Department of Clinical Research and Innovation and Laboratory of Pharmacology, UPRES EA220, Hôpital Foch, University Versailles Saint-Quentin en Yvelines, Suresnes, France (S.G.-D.); Department of Anesthesiology, Clinique Saint Augustin, Bordeaux, France (A.G.); Hôpital Foch, Suresnes, France (D.D.); Department of Anesthesiology, Hôpital Foch, University Versailles Saint-Quentin en Yvelines, Suresnes, France, and Department of Outcomes Research, Cleveland Clinic, Cleveland, Ohio (N.L.); Methodology and Statistics, Department of Clinical Research and Innovation, Hôpital Foch, Suresnes, France (J.-F.D.); Departments of Anesthesiology and of Intensive Care, Hôpital Bicêtre (Assistance Publique, Hôpitaux de Paris), Paris-Sud University, Le Kremlin-Bicêtre, France (J.-X.M.); Department of Clinical Research and Innovation and Laboratory of Pharmacology, UPRES EA220, Hôpital Foch, University Versailles Saint-Quentin en Yvelines, Suresnes, France (P.D., J.-C.A.); Department of Outcomes Research, Cleveland Clinic (D.I.S.); Department of Anesthesiology, Hôpital Foch, University Versailles Saint-Quentin en Yvelines, Suresnes, France (M.F.).
Morgan
M
Le Guen
Stanislas
S
Grassin-Delyle
Camille
C
Cornet
Antoine
A
Genty
Thierry
T
Chazot
Dominique
D
Dardelle
Ngai
N
Liu
Jean-François
JF
Dreyfus
Jean-Xavier
JX
Mazoit
Philippe
P
Devillier
Jean-Claude
JC
Alvarez
Daniel I
DI
Sessler
Marc
M
Fischler
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000768:Anesthesia, General; D000771:Anesthesia, Intravenous; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects; D001784:Blood Gas Analysis; D002626:Chemistry, Pharmaceutical; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000187:drug effects; D019999:Pharmaceutical Solutions; D015742:Propofol / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D018686:Anesthetics, Intravenous; D019999:Pharmaceutical Solutions; D015742:Propofol