Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.
- Registration Number
- NCT04556370
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 180
- 18-45 years
- Primipara or multipara
- Singleton pregnancy ≥32 weeks
- American Society of Anesthesiologists physical status classification II to III
- Scheduled for cesarean section under spinal anesthesia
- Baseline blood pressure ≥180 mmHg
- Body height < 150 cm
- Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- Eclampsia or chronic hypertension
- Hemoglobin < 7g/dl
- Fetal distress, or known fetal developmental anomaly
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Normal saline Normal saline infusion simultaneous with subarachnoid block 0.025 μg/kg/min group Norepinephrine A maintenance dose of norepinephrine (0.025 μg/kg/min) infusion simultaneous with subarachnoid block 0.050 μg/kg/min group Norepinephrine A maintenance dose of norepinephrine (0.050 μg/kg/min) infusion simultaneous with subarachnoid block 0.075 μg/kg/min group Norepinephrine A maintenance dose of norepinephrine (0.075 μg/kg/min) infusion simultaneous with subarachnoid block
- Primary Outcome Measures
Name Time Method The incidence of post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 80% of the baseline
- Secondary Outcome Measures
Name Time Method Overall stability of systolic blood pressure control versus baseline 1-15 minutes after spinal anesthesia Evaluated by performance error (PE)
Overall stability of heart rate control versus baseline 1-15 minutes after spinal anesthesia Evaluated by performance error (PE)
The incidence of severe post-spinal anesthesia hypotension 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \< 60% of the baseline
The incidence of nausea and vomiting 1-15 minutes after spinal anesthesia Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of bradycardia 1-15 minutes after spinal anesthesia Heart rate \< 55 beats/min
Base excess Immediately after delivery From umbilical arterial blood gases.
The incidence of hypertension. 1-15 minutes after spinal anesthesia Systolic blood pressure (SBP) \>120% of the baseline.
pH Immediately after delivery From umbilical arterial blood gases.
Partial pressure of oxygen Immediately after delivery From umbilical arterial blood gases.
APGAR score 5 min after delivery A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Trial Locations
- Locations (1)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China