Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia

Not Applicable

Completed

• Conditions: Adverse Effect
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT04556357
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2020-09-22
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-15
• Last Update Submitted: 2021-11-25
• Last Update Posted: 2021-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Phenylephrine	Phenylephrine infusion simultaneous with subarachnoid block
Norepinephrine group	Norepinephrine	Norepinephrine infusion simultaneous with subarachnoid block

Primary Outcome Measures

Name	Time	Method
The incidence of bradycardia	1-15 minutes after spinal anesthesia.	Heart rate \< 60 beats/min

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)

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China