Maternal Cardiac Output Response to Rescue Norepinephrine and Phenylephrine Boluses in Patients With Severe Preeclampsia
- Conditions
- Hemodynamic Instability
- Interventions
- Registration Number
- NCT05035485
- Lead Sponsor
- General Hospital of Ningxia Medical University
- Brief Summary
The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for 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. However, hemodynamic effects of the rescue norepinephrine bolus is still unknown. The purpose of this study is to investigate the maternal cardiac output response to rescue norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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 Norepinephrine group Norepinephrine Rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred Phenylephrine group Phenylephrine Rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred
- Primary Outcome Measures
Name Time Method Systemic vascular resistance (SVR) 1-30 minutes after spinal anesthesia Evaluated by the VIGILCO monitoring system.
Cardiac output (CO) 1-30 minutes after spinal anesthesia. Evaluated by the VIGILCO monitoring system.
Stroke volume (SV) 1-30 minutes after spinal anesthesia Evaluated by the VIGILCO monitoring system.
- Secondary Outcome Measures
Name Time Method The incidence of nausea and vomiting. 1-30 minutes after spinal anesthesia Presence of nausea and vomiting in patients after spinal anesthesia
APGAR score 5 min after delivery A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
Partial pressure of oxygen (PO2) Immediately after delivery From umbilical arterial blood gases.
Overall stability of heart rate control versus baseline 1-30 minutes after spinal anesthesia Evaluated by performance error (PE)
The incidence of hypertension. 1-30 minutes after spinal anesthesia Systolic blood pressure (SBP) \>120% of the baseline.
The incidence of bradycardia. 1-30 minutes after spinal anesthesia Heart rate \< 60 beats/min.
Overall stability of systolic blood pressure control versus baseline 1-30 minutes after spinal anesthesia Evaluated by performance error (PE)
The incidence of post-spinal anesthesia hypotension 1-30 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 80% of the baseline
The incidence of severe post-spinal anesthesia hypotension. 1-30 minutes after spinal anesthesia. Systolic blood pressure (SBP) \< 60% of the baseline
pH Immediately after delivery From umbilical arterial blood gases.
Base excess (BE) Immediately after delivery From umbilical arterial blood gases.
Trial Locations
- Locations (1)
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China