Effects of prophylactic infusion of equivalent doses of metaraminol and norepinephrine for preventing spinal anesthesia-induced hypotension during cesarean delivery on fetal and maternal outcomes: a dual-center, non-inferiority randomized clinical trial.

BACKGROUND

Few studies directly compared the effects of metaraminol and norepinephrine on maternal and neonatal outcomes during cesarean delivery. Moreover, the infusion rates are often based on clinical experience rather than high-quality evidence, leading to non-equivalent dosing. This study aims to validate and compare metaraminol and norepinephrine at their 90% effective dose (ED 90 ) in obstetric anesthesia.

MATERIALS AND METHODS

One hundred parturients undergoing cesarean delivery were randomly assigned to receive either 2.00 μg/kg/min of metaraminol (Group ME) or 0.10 μg/kg/min of norepinephrine (Group NE) to prevent spinal anesthesia-induced hypotension (SAIH). The primary outcomes were neonatal umbilical arterial (UA) pH and incidence of SAIH. Secondary outcomes included hemodynamic changes during the first 15 minutes, maternal adverse events, and additional neonatal outcome parameters.

RESULTS

Among the 94 participants who completed the study, the UA pH in Group ME [mean: 7.298; 95% confidence interval (CI): 7.255-7.341] was non-inferior to that in Group NE (mean: 7.296; 95% CI: 7.255-7.337), with a mean difference of 0.003 (95% CI: - 0.017 to 0.023), which is within the predefined non-inferiority margin of 0.02 pH units (non-inferiority P = 0.012). The incidence of SAIH was 13.0% in Group ME and 8.3% in Group NE (P = 0.701). No significant differences were observed in hypertension, bradycardia, nausea, and vomiting. Systolic blood pressure (SBP) measurements were comparable between the groups during the first 15 minutes. Additionally, Group NE had a higher heart rate (HR) than Group ME at most time points. Neonatal outcomes were comparable except for a higher UA pO 2 in Group ME.

CONCLUSION

Prophylactic infusion of metaraminol at 2.00 μg/kg/min is non-inferior to norepinephrine at 0.10 μg/kg/min in terms of neonatal outcomes, as assessed by umbilical arterial pH. Our findings further support the use of metaraminol as a suitable vasopressor in obstetric anesthesia for low-risk populations.