BMJ open · 2026
Prophylactic norepinephrine versus phenylephrine infusion on postpartum blood glucose in women undergoing caesarean section: a randomised controlled trial protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Zhang Kaiying, Cao Haifeng, Ji Huanghuang, Yu Gaoxu, Wu Liang, Shen Qiqing, Qian Wei, Tao Wenhui
Аннотация
INTRODUCTION: Norepinephrine (NE) and phenylephrine (PE) are routinely administered vasopressors used to maintain haemodynamic stability during caesarean section. Emerging evidence suggests that sustained infusion of these agents may disrupt maternal blood glucose regulation. This randomised controlled trial aims to compare the effects of NE and PE infusion on changes in postpartum blood glucose levels, insulin concentrations and insulin resistance in women after caesarean delivery.
METHODS ANALYSIS: In this double-blind, randomised trial, 100 eligible parturients will receive prophylactic intravenous infusion of either NE or PE at a rate of 30 mL/hour immediately after subarachnoid anaesthesia, continuing until the end of surgery. The primary outcome is the difference between maternal preoperative and immediate postoperative blood glucose levels. Secondary outcomes include immediate and 6-hour postoperative insulin levels, as well as Homeostasis Model Assessment of Insulin Resistance.
ETHICS AND DISSEMINATION: The Institutional Ethics Committee of Xuancheng People's Hospital approved the trial protocol (ID: 2025-yjky022-02). Findings will be published in an appropriate journal, and original data will be made available in November 2029 via the ResMan primary data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).
TRIAL REGISTRATION NUMBER: ChiCTR2500107683.
METHODS ANALYSIS: In this double-blind, randomised trial, 100 eligible parturients will receive prophylactic intravenous infusion of either NE or PE at a rate of 30 mL/hour immediately after subarachnoid anaesthesia, continuing until the end of surgery. The primary outcome is the difference between maternal preoperative and immediate postoperative blood glucose levels. Secondary outcomes include immediate and 6-hour postoperative insulin levels, as well as Homeostasis Model Assessment of Insulin Resistance.
ETHICS AND DISSEMINATION: The Institutional Ethics Committee of Xuancheng People's Hospital approved the trial protocol (ID: 2025-yjky022-02). Findings will be published in an appropriate journal, and original data will be made available in November 2029 via the ResMan primary data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).
TRIAL REGISTRATION NUMBER: ChiCTR2500107683.