Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Overview

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 Title of Study: “Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: November 15, 2021

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.

Interventions

  • Drug: Phenylephrine
    • A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
  • Drug: Norepinephrine
    • A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block

Arms, Groups and Cohorts

  • Active Comparator: Control group
    • Phenylephrine infusion simultaneous with subarachnoid block
  • Experimental: Norepinephrine group
    • Norepinephrine infusion simultaneous with subarachnoid block

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of bradycardia
    • Time Frame: 1-15 minutes after spinal anesthesia.
    • Heart rate < 60 beats/min

Secondary Measures

  • Overall stability of systolic blood pressure control versus baseline
    • Time Frame: 1-15 minutes after spinal anesthesia
    • Evaluated by performance error (PE)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • General Hospital of Ningxia Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xinli Ni, Dr., Study Chair, General Hospital of Ningxia Medical University

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