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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06741410
Enrollment
94
Registered
2024-12-19
Start date
2024-12-16
Completion date
2025-09-16
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery, Neonatal Acidosis, Spinal Anesthesia

Keywords

cesarean delivery, spinal anesthesia, phenylephrine, ephedrine, hypotension

Brief summary

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

Detailed description

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.

Interventions

DRUGEphedrine

Intravenous boluses of ephedrine

DRUGPhenylephrine

Intravenous continuous infusion of phenylephrine

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Umbilical blood pHDuring 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.
Umbilical blood Base Excess (BE)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

MeasureTime frameDescription
Hemodynamic stabilityDuring 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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026