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

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

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 Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
          • Yi Chen, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phenylephrine group
Phenylephrine infusion simultaneous with spinal anesthesia
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
A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
Other Names:
  • Vasopressors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output (CO)
Time Frame: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
1-30 minutes after spinal anesthesia
Stroke volume (SV)
Time Frame: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
1-30 minutes after spinal anesthesia
Systemic vascular resistance (SVR)
Time Frame: 1-30 minutes after spinal anesthesia
Evaluated by the VIGILCO monitoring system
1-30 minutes after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pH
Time Frame: Immediately after delivery
From umbilical arterial blood gases.
Immediately after delivery
APGAR score
Time Frame: 1 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
1 min after delivery
APGAR score
Time Frame: 5 min after delivery
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
5 min after delivery
Partial pressure of oxygen (PO2)
Time Frame: Immediately after delivery
From umbilical arterial blood gases.
Immediately after delivery
Base excess (BE)
Time Frame: Immediately after delivery
From umbilical arterial blood gases.
Immediately after delivery
Overall stability of systolic blood pressure control versus baseline
Time Frame: 1-30 minutes after spinal anesthesia
Evaluated by performance error (PE)
1-30 minutes after spinal anesthesia
Overall stability of heart rate control versus baseline
Time Frame: 1-30 minutes after spinal anesthesia
Evaluated by performance error (PE)
1-30 minutes after spinal anesthesia
The incidence of post-spinal anesthesia hypotension
Time Frame: 1-30 minutes after spinal anesthesia.
Systolic blood pressure (SBP) < 80% of the baseline
1-30 minutes after spinal anesthesia.
The incidence of severe post-spinal anesthesia hypotension.
Time Frame: 1-30 minutes after spinal anesthesia.
Systolic blood pressure (SBP) < 60% of the baseline
1-30 minutes after spinal anesthesia.
The incidence of nausea and vomiting.
Time Frame: 1-30 minutes after spinal anesthesia
Presence of nausea and vomiting in patients after spinal anesthesia
1-30 minutes after spinal anesthesia
The incidence of bradycardia.
Time Frame: 1-30 minutes after spinal anesthesia
Heart rate < 60 beats/min.
1-30 minutes after spinal anesthesia
The incidence of hypertension.
Time Frame: 1-30 minutes after spinal anesthesia
Systolic blood pressure (SBP) >120% of the baseline.
1-30 minutes after spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Xinli Ni, Dr., General Hospital of Ningxia Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

April 21, 2025

Study Completion (Estimated)

April 21, 2025

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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