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A randomized, prospective double-blind comparison of the efficacy of generic propofol (sulphite additive) with Diprivan®

Published online by Cambridge University Press:  27 January 2006

A. J. Olufolabi ,
T. J. Gan ,
H. J. Lacassie ,
W. D. White  and
A. S. Habib
A. J. Olufolabi
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
T. J. Gan
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
H. J. Lacassie
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
W. D. White
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
A. S. Habib
Affiliation:
Duke University Medical Center, Department of Anesthesiology, Division of Women's Anaesthesia Research Group
Includes J. R. Schultz, F. A. Jose, T. W. Breen, P. D. Dwane, M. K. Panni, H. A. Muir.
, Durham, NC, USA
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Extract

Summary

Background and objective: We compared the dose requirement and side effect profile of total intravenous anaesthesia using Diprivan® to generic propofol at a specific anaesthetic target level utilizing the bispectral index monitor to determine efficacy differences between the two products. Methods: Sixty women undergoing abdominal hysterectomy were induced with propofol 2 mg kg−1 and maintained with infusion (20–200 μg kg−1 min−1) adjusted to maintain a bispectral index of 50–65. Plasma propofol concentration was measured at 1 and 2 h post induction in 25 patients. Results: Mean (SD) drug doses adjusted for weight and time were similar in the Diprivan® and generic propofol groups: 90 (30) μg kg−1 min−1 vs. 90 (20) μg kg−1 min−1 respectively. Mean (SD) plasma propofol levels at 1 and 2 h were also similar (3.0 (1.0) μg mL−1 vs. 3.6 (1.4) μg mL−1, P = 0.2 and 3.0 (1.9) μg mL−1 vs. 3.4 (1.6) μg mL−1, P = 0.58). Conclusions: Diprivan® and generic propofol have similar efficacy at a specified, bispectral index-defined, depth of anaesthesia.

Keywords

ANAESTHETICS INTRAVENOUS, propofolDRUGS GENERICTHERAPEUTIC EQUIVALENCYANESTHESIA, GENERAL, bispectral index
Type
Original Article
Information
European Journal of Anaesthesiology , Volume 23 , Issue 4 , April 2006 , pp. 341 - 345
Copyright
© 2006 European Society of Anaesthesiology

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