British Journal of Anaesthesia, Vol 78, Issue 6 642-651, Copyright © 1997 by The Board of Management and Trustees of the British Journal of Anaesthesia
M. R. Tramer, R. A. Moore and H. J. McQuay
As part of the development of a model for the study of adverse events, we
have investigated the risk of bradycardia with propofol. A systematic
search for any type of report, published and unpublished, was made to
review the evidence that propofol increases the risk of bradycardia,
asystole and death from bradycardic events. Quantitative and qualitative
analyses of data with different strengths of evidence were performed.
Sixty-five published and 187 spontaneous reports to drug monitoring centres
described with different strength of evidence a biological basis for
propofol-induced bradycardia, 1444 bradycardias, 86 asystoles and 24
deaths. In controlled clinical trials, propofol significantly increased the
risk of bradycardia compared with other anaesthetics (number-needed-to-harm
11.3 (95% confidence interval 7.7- 21)). In paediatric strabismus surgery
the number-needed-to-harm was 4.1 (3-6.7). One of 660 patients undergoing
propofol anaesthesia had an asystole. The risk of bradycardia-related death
during propofol anaesthesia was estimated to be 1.4 in 100,000. Data from
the phase IV study of propofol did not agree with data from controlled
studies. Propofol carries a finite risk for brady-cardia with potential for
major harm. Study of adverse events should be made with systematically
searched data and, in contrast with study of efficacy, not restricted to
randomized, controlled trials.
CLINICAL INVESTIGATIONS
Propofol and bradycardia: causation, frequency and severity
Pain Research, Nuffield Department of Anaesthetics, The Churchill, Oxford Radcliffe Hospital, Headington, Oxford OX3 7LJ
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