This study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section.
Spinal anesthesia-induced hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of spinal anesthesia-induced hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage spinal anesthesia-induced hypotension. The prophylactic vasopressor strategy is more effective in enhancing hemodynamic stability and reducing adverse events such as nausea and vomiting during cesarean section, compared to rescue strategy. However, it does not demonstrate significant advantages in neonatal outcomes such as umbilical artery pH and Apgar score. The impact of various vasopressor application patterns on neonatal outcomes after cesarean section lacks further supporting evidence. Therefore, this study aims to explore the effects of different application modes (prophylactic and rescue strategy) of norepinephrine and norepinephrine on neonate umbilical artery pH undergoing cesarean section through a multicenter, single-blind, 2\*2 crossover and cluster randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension
Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
pH
From umbilical arterial blood gases.
Time frame: Immediately after delivery
Base excess (BE)
From umbilical arterial blood gases.
Time frame: Immediately after delivery
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
The incidence of severe post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 60% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia
Heart rate \< 60 beats/min
Time frame: 1-15 minutes after spinal anesthesia
The incidence of nausea and vomiting
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of hypertension
Systolic blood pressure (SBP) \>120% of the baseline.
Time frame: 1-15 minutes after spinal anesthesia
Partial pressure of oxygen (PO2)
From umbilical arterial blood gases.
Time frame: Immediately after delivery
APGAR score
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A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 1 min after delivery
APGAR score
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5 min after delivery