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

NCT ID: NCT06741410

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2025-09-16

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.

Conditions

Spinal Anesthesia; Cesarean Delivery; Neonatal Acidosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Ephedrine

Intervention Type: DRUG

Intravenous boluses of 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.

Phenylephrine

Intervention Type: DRUG

Intravenous continuous infusion of phenylephrine

Interventions

Ephedrine

Intravenous boluses of ephedrine

Intervention Type: DRUG

Phenylephrine

Intravenous continuous infusion of phenylephrine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Bartosz Horosz, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Małgorzata Malec-Milewska, MD, Prof.

Role: STUDY_CHAIR

Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Locations

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

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 19672175 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28953494 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27020488 (View on PubMed)

Other Identifiers

96/2024

Identifier Type: -

Identifier Source: org_study_id