Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

General Hospital of Ningxia Medical University

Status: Completed

Conditions: Adverse Effect

Treatments: Drug: Phenylephrine; Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04556357

Yi Chen-2020-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 2 patient groups

Control group

Active Comparator group

Description:

Phenylephrine infusion simultaneous with subarachnoid block

Treatment:

Drug: Phenylephrine

Norepinephrine group

Experimental group

Description:

Norepinephrine infusion simultaneous with subarachnoid block

Treatment:

Drug: Norepinephrine