General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
NCT Number: NCT06508359
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Yinchuan, Ningxia, 750004, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prophylactic or rescue norepinephrine for spinal anesthesia-induced hypotension
Other names: Vasopressor
Prophylactic or rescue phenylephrine for spinal anesthesia-induced hypotension
Other names: Vasopressor
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) < 60% of the baseline
Time frame: 1-15 minutes after spinal anesthesia
Heart rate < 60 beats/min
Time frame: 1-15 minutes after spinal anesthesia
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline.
Time frame: Immediately after delivery
From umbilical arterial blood gases.
Time frame: 1 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Time frame: 5 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
General Hospital of Ningxia Medical University
Other
Prophylactic vs Rescue Norepinephrine and Phenylephrine for Spinal Anesthesia-induced Hypotension on Neonatal Outcomes During Cesarean Section: A Multicenter, Single-blind, Crossover, Factorial Cluster Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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