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Completed

NCT Number: NCT06741410

Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

The study is designed to compare two strategies used in the management of hypotension caused by spinal anesthesia for cesarean section: intravenous phenylephrine given as prophylactic infusion and interventional boluses of intravenous ephedrine. Phenylephrine is currently recommended for battling spinal anesthesia - related sympathectomy, due to some scientific data on possible negative effects of ephedrine on fetal wellbeing. Therefore this study will retrospectively compare both clinical and laboratory data of the newborns delivered by cesarean section where either large dose of ephedrine or continuous infusion of phenylephrine was used for management of hypotension

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Key information

Conditions

Spinal Anesthesia Cardiovascular Diseases Cesarean Delivery Hypotension Neonatal Acidosis Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Warsaw, 01-813, Poland

About this study

Single - shot spinal block is a gold standard of anesthesia for cesarean delivery. It has been proven to decrease maternal morbidity and improve neonatal outcomes. Despite being most frequently used type of anesthesia in obstetrics, spinal block - related complications remain frequent in term parturients, of which hypotension is of utmost importance. Two widely accepted medications used in its prevention and treatment are phenylephrine and ephedrine, of which continuous, preventive phenylephrine infusion is considered superior in terms of neonatal safety.

Although there is some scientific evidence towards ephedrine having negative effect on neonatal acid - base status, it is still the most popular vasoconstrictor used for management of perioperative hypotension in Poland. It is an indirect adrenergic agonist, acting through release of noradrenaline from peripheral nerve endings. Beta - receptors mediated adrenergic stimulation of neonatal tissues is thought to be responsible for endocrine abnormalities, acid - base disturbances and possibly worse Apgar scores. Phenylephrine on the other hand is a direct and selective alpha-1 agonist and is regarded to exert very little or even no neonatal effects. Maternal complications related to phenylephrine infusion is hypertension and reflex bradycardia.

As convincing evidence is still lacking, this study is designed to retrospectively compare neonatal outcomes and perioperative hemodynamic data of mothers where either infusion of phenylephrine or boluses of ephedrine were used to control spinal -related hypotension during cesarean section.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cesarean delivery at term under spinal anesthesia
  • American Society of Anesthesiologists (ASA) physical status <3
  • BMI <40
  • Preemptive phenylephrine infusion or ephedrine boluses used during surgical procedure

Exclusion criteria

  • No vasoconstrictor (phenylephrine nor ephedrine) used throughout the procedure
  • Total dose of ephedrine less than 15mg
  • poor quality of anesthetic record - data required for analysis not available

Treatment and study plan

Ephedrine

Drug

Intravenous boluses of ephedrine

Phenylephrine

Drug

Intravenous continuous infusion of phenylephrine

Primary outcomes

  1. Umbilical blood pH

    Time frame: During delivery (from spinal injection to umbilical clamping and cutting)

    Sets of data will be tested for normality and standard statistical tests (Student's t - test or Mann - Whitney U - test) will be used to detect the differences in umbilical blood pH between the groups.

  2. Umbilical blood Base Excess (BE)

    Time frame: During delivery (from spinal injection to umbilical clamping and cutting)

    Sets of data will be tested for normality and standard statistical tests (Student's t - test or Mann - Whitney U - test) will be used to detect the differences in umbilical blood Base Excess (BE) between the groups.

Secondary outcomes

  1. Hemodynamic stability

    Time frame: During delivery (from spinal injection to umbilical clamping and cutting)

    Number of episodes of hypotension recorded in anesthetic sheet after spinal injection will be compared using chi-square or Fisher's exact test.

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

The Effect of Prophylactic Phenylephrine Infusion and Interventional Ephedrine Boluses on Umbilical Blood pH in Women Undergoing Cesarean Delivery Under Spinal Anesthesia: a Retrospective Case - Control Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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