A randomized comparison of hemodynamic changes in response to a heart rate-dependent phenylephrine/ephedrine protocol versus ephedrine-only for spinal hypotension during elective cesarean section

J Obstet Gynaecol Res. 2022 Jul;48(7):1750-1759. doi: 10.1111/jog.15289. Epub 2022 May 22.

Abstract

Aim: To compare incidences of abnormal heart rate (HR) between the phenylephrine/ephedrine protocol (P/E protocol) against the ephedrine-only (C) protocol, conventionally used for treating predelivery hypotension following spinal anesthesia for cesarean section.

Methods: Two hundred and sixty-eight parturients with pre-delivery hypotension after spinal anesthesia were equally randomized to (1) Group P/E (n = 134), phenylephrine 100 mcg in 10 mL intravenously if HR ≥ 60 beats/min (bpm), or ephedrine 6 mg intravenously if HR < 60 bpm, and 2) Group C (n = 134). The primary outcome was the incidence of the parturients with abnormal HR after vasopressor administration. The secondary outcome was the mean differences of HR and hypotensive periods during the pre-delivery period.

Results: There was no significant difference of between-group incidences of bradycardia (12.0% in Group P/E vs 6.7% in Group C, p = 0.136) and tachycardia (26.9% vs 35.8%, p = 0.114). Mean HR was 81.9 bpm (95% confidence interval [CI] 79.9, 84.3) in Group P/E, and 88.8 bpm (86.8, 90.6) in Group C (p < 0.001). The duration of hypotension in relation to the time interval from spinal anesthesia to delivery was 20.9% (95% CI 18.4-23.2) in Group P/E, and 26.5% (23.9-29.3) in Group C (p < 0.01). The calculated area under the curve (AUC) of abnormal HR in relation to time was significantly reduced only in Group P/E (p < 0.010).

Conclusions: The incidences of out-of-range HR were comparable, but the P/E protocol resulted in a lower mean HR and better control of systolic blood pressure than the ephedrine-only protocol.

Keywords: cesarean; ephedrine; heart rate; phenylephrine; spinal.

Publication types

  • Clinical Trial Protocol
  • Comparative Study

MeSH terms

  • Anesthesia, Obstetrical* / adverse effects
  • Anesthesia, Spinal* / adverse effects
  • Cesarean Section*
  • Clinical Protocols
  • Double-Blind Method
  • Ephedrine* / adverse effects
  • Ephedrine* / pharmacology
  • Ephedrine* / therapeutic use
  • Female
  • Heart Rate* / drug effects
  • Hemodynamics
  • Humans
  • Hypotension* / drug therapy
  • Hypotension* / etiology
  • Phenylephrine* / adverse effects
  • Phenylephrine* / pharmacology
  • Phenylephrine* / therapeutic use
  • Pregnancy

Substances

  • Phenylephrine
  • Ephedrine