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CLINICAL TRIAL REPORT

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

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Pages 639-650 | Received 26 Oct 2023, Accepted 08 Feb 2024, Published online: 29 Feb 2024
 

Abstract

Background

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.

Abbreviations

PSH, postspinal hypotension; BP, blood pressure; ASA, American Society of Anesthesiologists physical status; LUD, left uterine displacement; MAP, mean arterial pressure; HR, heart rate; CO, cardiac output; SV= hydroxyethyl starch; SVR= systemic vascular resistance.

Article Highlights

● In patients with severe pre-eclampsia, phenylephrine and norepinephrine showed similar umbilical arterial pH for treating of post-spinal hypotension.

● Compared with phenylephrine, norepinephrine provided greater maternal cardiac output and a lower incidence of bradycardia.

Data Sharing Statement

The data that support the findings of the study are available from the corresponding author upon reasonable request.

Ethics Approval and Consent to Participate

This study was approved by the Ethics Committee of Women’s Hospital, Zhejiang University School of Medicine (Hangzhou, China) (Approval No. IRB-20211038-R), registered at the Chinese Clinical Trial Registry (www. chictr.org.cn, registration No. ChiCTR2100047529, principal investigator: Xiao-Wei Qian). Informed written consents were obtained from all subjects.We confirm our study complies with the Declaration of Helsinki.

Consent for Publication

All authors have read and approved the manuscript, and agreed to submit to your journal.

Acknowledgments

Assistance with the study: The authors thank all the colleagues in the Department of Anesthesiology, Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

Disclosure

The authors declare no conflicts of interest in this work.

Additional information

Funding

Financial support and sponsorship: none.