An interventional study of Normal saline and Norepinephrine in Adverse Effect, sponsored by General Hospital of Ningxia Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by General Hospital of Ningxia Medical University · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 180 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →General Hospital of Ningxia Medical University is the lead sponsor of 102 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Normal saline infusion simultaneous with subarachnoid block
Drug: Normal saline
A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block
Drug: Norepinephrine
A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block
Drug: Norepinephrine
A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block
Drug: Norepinephrine
Normal saline infusion simultaneous with subarachnoid block
Also known as: NS
Different infusion dose of norepinephrine simultaneous with subarachnoid block
Also known as: Vasopressors
The incidence of post-spinal anesthesia hypotension
Systolic blood pressure (SBP) \< 80% of the baseline
Time frame: 1-15 minutes after spinal anesthesia.
Overall stability of systolic blood pressure control versus baseline
Evaluated by performance error (PE)
Time frame: 1-15 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
Evaluated by performance error (PE)
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 nausea and vomiting
Presence of nausea and vomiting in patients after spinal anesthesia
Time frame: 1-15 minutes after spinal anesthesia
The incidence of bradycardia
Heart rate \< 55 beats/min
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
pH
From umbilical arterial blood gases.
Time frame: Immediately after delivery
Partial pressure of oxygen
From umbilical arterial blood gases.
Time frame: Immediately after delivery
Base excess
From umbilical arterial blood gases.
Time frame: Immediately after delivery
APGAR score
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
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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General Hospital of Ningxia Medical University