Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia

Not Applicable

Recruiting

• Conditions: Hemodynamic Instability
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT05035498
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion 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 prophylactic norepinephrine infusion is still unknown. The purpose of this study is to investigate the maternal cardiac output response to prophylactic norepinephrine and phenylephrine infusion for postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Study Start: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2025-04-21
• Study Completion: 2025-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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
Phenylephrine group	Phenylephrine	Phenylephrine infusion simultaneous with spinal anesthesia
Norepinephrine group	Norepinephrine	Norepinephrine infusion simultaneous with spinal anesthesia

Primary Outcome Measures

Name	Time	Method
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
Systemic vascular resistance (SVR)	1-30 minutes after spinal anesthesia	Evaluated by the VIGILCO monitoring system

Secondary Outcome Measures

Name	Time	Method
Overall stability of systolic blood pressure control versus baseline	1-30 minutes after spinal anesthesia	Evaluated by performance error (PE)
Overall stability of heart rate 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
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.
The incidence of nausea and vomiting.	1-30 minutes after spinal anesthesia	Presence of nausea and vomiting in patients after spinal anesthesia
pH	Immediately after delivery	From umbilical arterial blood gases.
Partial pressure of oxygen (PO2)	Immediately after delivery	From umbilical arterial blood gases.
Base excess (BE)	Immediately after delivery	From umbilical arterial blood gases.
APGAR score	5 min after delivery	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Trial Locations

Locations (1)

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