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

Hemodynamic Instability Clinical Trial

Official title:

Comparison of Prophylactic Norepinephrine and Phenylephrine Infusion for Hemodynamic Effects in Patients With Preeclampsia During Cesarean Section: a Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035498
• Other study ID #: Yi Chen-2021-1
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 21, 2025

Study information

• Verified date: January 2024
• Source: General Hospital of Ningxia Medical University
• Contact: Xinli Ni, Dr.
• Phone: 86-951-674-3252
• Email: xinlini6[@]nyfy.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 21, 2025
• Est. primary completion date: April 21, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Pre-Eclampsia

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output (CO)	Evaluated by the VIGILCO monitoring system	1-30 minutes after spinal anesthesia
Primary	Stroke volume (SV)	Evaluated by the VIGILCO monitoring system	1-30 minutes after spinal anesthesia
Primary	Systemic vascular resistance (SVR)	Evaluated by the VIGILCO monitoring system	1-30 minutes after spinal anesthesia
Secondary	Overall stability of systolic blood pressure control versus baseline	Evaluated by performance error (PE)	1-30 minutes after spinal anesthesia
Secondary	Overall stability of heart rate control versus baseline	Evaluated by performance error (PE)	1-30 minutes after spinal anesthesia
Secondary	The incidence of post-spinal anesthesia hypotension	Systolic blood pressure (SBP) < 80% of the baseline	1-30 minutes after spinal anesthesia.
Secondary	The incidence of severe post-spinal anesthesia hypotension.	Systolic blood pressure (SBP) < 60% of the baseline	1-30 minutes after spinal anesthesia.
Secondary	The incidence of hypertension.	Systolic blood pressure (SBP) >120% of the baseline.	1-30 minutes after spinal anesthesia
Secondary	The incidence of bradycardia.	Heart rate < 60 beats/min.	1-30 minutes after spinal anesthesia
Secondary	The incidence of nausea and vomiting.	Presence of nausea and vomiting in patients after spinal anesthesia	1-30 minutes after spinal anesthesia
Secondary	pH	From umbilical arterial blood gases.	Immediately after delivery
Secondary	Partial pressure of oxygen (PO2)	From umbilical arterial blood gases.	Immediately after delivery
Secondary	Base excess (BE)	From umbilical arterial blood gases.	Immediately after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	1 min after delivery
Secondary	APGAR score	A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration	5 min after delivery