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

NCT06741410 | Completed

• 1 other identifier: 96/2024
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Anesthesia; Cesarean Delivery; Neonatal Acidosis

Keywords

cesarean delivery; spinal anesthesia; phenylephrine; ephedrine; hypotension

Outcome Measures

Primary Outcomes (2)

• Umbilical blood pH

  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.

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

• Umbilical blood Base Excess (BE)

  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.

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

Secondary Outcomes (1)

• Hemodynamic stability

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

Study Arms (2)

Ephedrine

Cesarean delivery cases where spinal block was administered and hypotension was managed with intravenous ephedrine. Hospital electronic database will be searched to identify cases of cesarean delivery in years 2020 - 2022. After that, manual review of the medical notes will follow in order to extract cases where spinal block was administered and ephedrine was used to treat spinal - related hypotension. Further chart analysis will yield demographic and hemodynamic data of the parturient, as well as clinical data of the neonate (weight, gender, Apgar score). Further laboratory data on neonatal acid - base status will be acquired from hospital's laboratory electronic database. Attention will be paid to assure that identification of the patients would not be possible using data acquired for the study. All data will be anonymized and accessible only for investigators.

Drug: Ephedrine

Phenylephrine

Cesarean delivery cases where spinal block was administered and hypotension was managed with intravenous phenylephrine infusion Hospital electronic database will be searched to identify cases of cesarean delivery in years 2020 - 2022. After that, manual review of the medical notes will follow in order to extract cases where spinal block was administered and infusion of phenylephrine was used to treat spinal - related hypotension. Further chart analysis will yield demographic and hemodynamic data of the parturient, as well as clinical data of the neonate (weight, gender, Apgar score). Further laboratory data on neonatal acid - base status will be acquired from hospital's laboratory electronic database. Attention will be paid to assure that identification of the patients would not be possible using data acquired for the study. All data will be anonymized and accessible only for investigators.

Drug: Phenylephrine

Interventions

Ephedrine DRUG

Intravenous boluses of ephedrine

Ephedrine

Phenylephrine DRUG

Intravenous continuous infusion of phenylephrine

Phenylephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initial cohort of patients will consist of selected cases of cesarean deliveries from Orlowski Hospital in years 2020 - 2022, Department of Obstetrics and Gynaecology, Warsaw, Poland. Intention is to include 40 cases in each group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

Warsaw, 01-813, Poland

Location

Related Publications (3)

• Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.

  PMID: 19672175 BACKGROUND

• Higgins N, Fitzgerald PC, van Dyk D, Dyer RA, Rodriguez N, McCarthy RJ, Wong CA. The Effect of Prophylactic Phenylephrine and Ephedrine Infusions on Umbilical Artery Blood pH in Women With Preeclampsia Undergoing Cesarean Delivery With Spinal Anesthesia: A Randomized, Double-Blind Trial. Anesth Analg. 2018 Jun;126(6):1999-2006. doi: 10.1213/ANE.0000000000002524.

  PMID: 28953494 BACKGROUND

• Mohta M, Aggarwal M, Sethi AK, Harisinghani P, Guleria K. Randomized double-blind comparison of ephedrine and phenylephrine for management of post-spinal hypotension in potential fetal compromise. Int J Obstet Anesth. 2016 Aug;27:32-40. doi: 10.1016/j.ijoa.2016.02.004. Epub 2016 Feb 21.

  PMID: 27020488 BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Ephedrine; Phenylephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Ethanolamines

Study Officials

• Małgorzata Malec-Milewska, MD, Prof.

  Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 19, 2024
• Study Start: December 16, 2024
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

PL (1)