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

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05035498

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability	Drug: Phenylephrine Drug: Norepinephrine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phenylephrine group Phenylephrine infusion simultaneous with spinal anesthesia	Drug: Phenylephrine A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block Other Names: Vasopressors
Experimental: Norepinephrine group Norepinephrine infusion simultaneous with spinal anesthesia	Drug: Norepinephrine A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block Other Names: Vasopressors

Arm

Intervention/Treatment

Active Comparator: Phenylephrine group

Phenylephrine infusion simultaneous with spinal anesthesia

Drug: Phenylephrine

A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block

Other Names:

Vasopressors

Experimental: Norepinephrine group

Norepinephrine infusion simultaneous with spinal anesthesia

Drug: Norepinephrine

A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block

Other Names:

Vasopressors

Outcome Measures

Primary Outcome Measures

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

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 [1 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score [5 min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration