Drug Design, Development and Therapy (Feb 2024)
Randomized Double-Blinded Comparison of Intermittent Boluses Phenylephrine and Norepinephrine for the Treatment of Postspinal Hypotension in Patients with Severe Pre-Eclampsia During Cesarean Section
Abstract
Zheng-Bin Pan,1,2 Zhi-Min Sheng,1 Miao Zhu,1 Zhong Mei,1 Yan-Ping Shen,1 Jin-Ping Liu,1 Xiao-Wei Qian1 1Department of Anesthesiology, Women’s Hospital, Zhejiang University School of Medicine, Hangzhou, People’s Republic of China; 2Department of Anesthesiology, Shaoxing Maternity and Child Health Care Hospital, Shaoxing, People’s Republic of ChinaCorrespondence: Xiao-Wei Qian, Department of Anesthesiology, Women’s Hospital, Zhejiang University School of Medicine, Xueshi Road 1, Hangzhou, 310006, People’s Republic of China, Email [email protected]: Norepinephrine has fewer negative effects on heart rate (HR) and cardiac output (CO) for treating postspinal hypotension (PSH) compared with phenylephrine during cesarean section. However, it remains unclear whether fetuses from patients with severe pre-eclampsia could benefit from the superiority of CO. The objective of this study was to compare the safety and efficacy of intermittent intravenous boluses of phenylephrine and norepinephrine used in equipotent doses for treating postspinal hypotension in patients with severe pre-eclampsia during cesarean section.Methods: A total of 80 patients with severe pre-eclampsia who developed PSH predelivery during cesarean section were included. Eligible patients were randomized at a 1:1 ratio to receive either phenylephrine or norepinephrine for treating PSH. The primary outcome was umbilical arterial pH. Secondary outcomes included other umbilical cord blood gas values, Apgar scores at 1 and 5 min, changes in hemodynamic parameters including CO, mean arterial pressure (MAP), HR, stroke volume (SV), and systemic vascular resistance (SVR), the number of vasopressor boluses required, and the incidence of bradycardia, hypertension, nausea, vomiting, and dizziness.Results: No significant difference was observed in umbilical arterial pH between the phenylephrine and norepinephrine groups (7.303± 0.38 vs 7.303± 0.44, respectively; P=0.978). Compared with the phenylephrine group, the overall CO (P=0.009) and HR (P=0.015) were greater in the norepinephrine group. The median [IQR] total number of vasopressor boluses required was comparable between the two groups (2 [1 to 3] and 2 [1 to 3], respectively; P=0.942). No significant difference was found in Apgar scores or the incidence of maternal complications between groups.Conclusion: A 60 μg bolus of phenylephrine and a 4.5 μg bolus of norepinephrine showed similar neonatal outcomes assessed by umbilical arterial pH and were equally effective when treating PSH during cesarean section in patients with severe pre-eclampsia. Norepinephrine provided a higher maternal CO and a lower incidence of bradycardia.Keywords: phenylephrine, norepinephrine, hypotension, umbilical arterial pH
