Spinal AnesthesiaNCT06741410
Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery
An observational study of Spinal Anesthesia and Cesarean Delivery, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia, Cesarean Delivery, Neonatal Acidosis
- What is being tested?
- Ephedrine and Phenylephrine
- Type of treatment
- Injection or infusion
- How many people
- 94 participants
- Where
- 1 sitePoland
- Study dates
- 16 Dec 2024to 16 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Warsaw, 01-813
About this study
Official 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
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
Read the 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
- Being tested
- Ephedrine, Phenylephrine
- Keywords
- cesarean delivery, spinal anesthesia, phenylephrine, ephedrine, hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
Intravenous boluses of ephedrine
PhenylephrineDrug
Intravenous continuous infusion of phenylephrine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During delivery (from spinal injection to umbilical clamping and cutting)
Secondary outcomes (1)
Hemodynamic stability
Number of episodes of hypotension recorded in anesthetic sheet after spinal injection will be compared using chi-square or Fisher's exact test.
Measured: During delivery (from spinal injection to umbilical clamping and cutting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start16 Dec 2024
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Horosz, MD, Centre of Postgraduate Medical Education
- Investigators
- Małgorzata Malec-Milewska, MD, Prof., Study chair, Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741410
- Sponsor's protocol ID
- 96/2024
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19672175Higgins 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.
PubMed 28953494Mohta 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.
PubMed 27020488
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06741410
- Acronym / sponsor ID
- 96/2024
- Conditions
- Spinal Anesthesia, Cesarean Delivery, Neonatal Acidosis
- Keywords
- cesarean delivery, spinal anesthesia, phenylephrine, ephedrine, hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ephedrine | – | Drug: EphedrineCesarean 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. |
| Phenylephrine | – | Drug: PhenylephrineCesarean 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EphedrineIntravenous boluses of ephedrine | Drug | Ephedrine |
| PhenylephrineIntravenous continuous infusion of phenylephrine | Drug | Phenylephrine |
Primary outcome
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.
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.
1 secondary outcome
Hemodynamic stability
Time frame: During delivery (from spinal injection to umbilical clamping and cutting)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 19672175Ngan 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.
- Background: PubMed 28953494Higgins 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.
- Background: PubMed 27020488Mohta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Malec-Milewska, MD, Prof. study chair
Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia and Cesarean Delivery, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical blood pH (time frame: During delivery (from spinal injection to umbilical clamping and cutting)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06741410, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.