Norepinephrine versus phenylephrine during spinal anaesthesia for caesarean delivery: a randomized double-blinded pragmatic non-inferiority study comparing neonatal outcome
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AbstractIntroduction: during spinal anaesthesia (SA) for caesarean delivery (CD) norepinephrine (NE) has the advantage of less depression of heart rate and cardiac output than phenylephrine (PE).1 However, there are limited data on neonatal outcome. In a randomized, double-blinded, pragmatic, non-inferiority trial we hypothesized that umbilical arterial (UA) cord pH with NE is at least as good (non-inferior) vs PE.
Methods: With IRB approval and informed consent, we randomized 668 women having SA for CD for a range of indications to receive PE 100 µg/mL or NE 6 µg/mL, given by the usual practice of anaesthetist in a pragmatic study design.2 The study had 90% power, with alpha 0.05, to reject the null hypothesis that UA pH is less with NE than with PE by 0.01 units or more in a non-inferiority analysis.3
Results: 533 elective and 135 non-elective patients completed the study. Accounting for unmeasurable samples and multiple gestations, UA pH was analysed for 349 samples for NE and 343 samples for PE. UA pH with NE was non-inferior vs PE (7.289 ± 0.049 vs 7.287 ± 0.046, Fig.). Secondary analysis showed no difference in US base excess for NE vs PE (-4.8 ± 2.6 vs -4.9 ± 2.8 mmol/L).
Discussion: during SA for CD, when BP is maintained using NE neonatal outcome, as measured by UA pH, is at least as good as when PE is used. These results suggest that there is no basis for concern for adverse effects on the neonate when using NE to maintain BP during SA for CD.
All Author(s) ListWD Ngan Kee, FF Ng, SWY Lee, A Lee
Journal nameInternational Journal of Obstetric Anesthesia
Detailed descriptionAbstracts of free papers presented at the annual meeting of the Obstetric Anaesthetists' Association, 2019
Volume Number39
Issue NumberSuppl. 1
PagesS7 - S7
LanguagesEnglish-United Kingdom

Last updated on 2021-20-09 at 23:33