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Clinical Trial
. 2001 May;48(5):459-61.
doi: 10.1007/BF03028308.

Hypnotic and cardiovascular effects of proprietary and generic propofol formulations do not differ

Affiliations
Clinical Trial

Hypnotic and cardiovascular effects of proprietary and generic propofol formulations do not differ

A Fassoulaki et al. Can J Anaesth. 2001 May.

Abstract

Purpose: The aim of the study was to compare the potency of two different propofol formulations: proprietary and generic propofol using the bispectral index (BIS) monitoring.

Methods: Forty female patients undergoing breast surgery received propofol 3 mg x kg(-1) followed by propofol infusion adjusted to maintain a 40% BIS value, supplemented by 50% nitrous oxide. Proprietary or generic propofol was administered in a randomized double-blind manner.

Results: The propofol mg/BIS% ratio obtained after the bolus dose, the cumulative infused propofol mg/BIS% ratio at the end of each five-minute interval and the total dose of propofol administered as bolus + infusion were similar between the two groups. The two groups did not differ with regard to systolic and diastolic blood pressure, heart rate, end-tidal carbon dioxide and arterial oxygen saturation.

Conclusion: The two propofol formulations are equipotent when hypnotic effect is assessed by BIS monitoring.

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