Neuromuscular dose-response studies: determining sample size.

Abstract:

BACKGROUND:Investigators planning dose-response studies of neuromuscular blockers have rarely used a priori power analysis to determine the minimal sample size their protocols require. Institutional Review Boards and peer-reviewed journals now generally ask for this information. This study outlines a proposed method for meeting these requirements. METHODS:The slopes of the dose-response relationships of eight neuromuscular blocking agents were determined using regression analysis. These values were substituted for γ in the Hill equation. When this is done, the coefficient of variation (COV) around the mean value of the ED₅₀ for each drug is easily calculated. Using these values, we performed an a priori one-sample two-tailed t-test of the means to determine the required sample size when the allowable error in the ED₅₀ was varied from ±10-20%. RESULTS:The COV averaged 22% (range 15-27%). We used a COV value of 25% in determining the sample size. If the allowable error in finding the mean ED₅₀ is ±15%, a sample size of 24 is needed to achieve a power of 80%. Increasing 'accuracy' beyond this point requires increasing greater sample sizes (e.g. an 'n' of 37 for a ±12% error). CONCLUSIONS:On the basis of the results of this retrospective analysis, a total sample size of not less than 24 subjects should be adequate for determining a neuromuscular blocking drug's clinical potency with a reasonable degree of assurance.

journal_name

Br J Anaesth

authors

Kopman AF,Lien CA,Naguib M

doi

10.1093/bja/aeq310

subject

Has Abstract

pub_date

2011-02-01 00:00:00

pages

194-8

issue

2

eissn

0007-0912

issn

1471-6771

pii

S0007-0912(17)33322-6

journal_volume

106

pub_type

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