Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Phenylephrine
- Conditions
- Adverse Effect
- Sponsor
- General Hospital of Ningxia Medical University
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- The incidence of bradycardia
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety 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 efficacy and safety in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the efficacy and safety of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control group
Phenylephrine infusion simultaneous with subarachnoid block
Intervention: Phenylephrine
Norepinephrine group
Norepinephrine infusion simultaneous with subarachnoid block
Intervention: Norepinephrine
Outcomes
Primary Outcomes
The incidence of bradycardia
Time Frame: 1-15 minutes after spinal anesthesia.
Heart rate \< 60 beats/min
Secondary Outcomes
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia)