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Maternal Hypotension After Spinal AnesthesiaNCT07899216

Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery

A study testing continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/ml, continious ephedrine infusion at a rate of 30 ml/min and Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min. in people with Maternal Hypotension After Spinal Anesthesia, run by Alexandria University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Background Spinal anaesthesia is the preferred anaesthetic technique for most elective Caesarean deliveries; however, maternal hypotension following spinal anaesthesia remains very common and may be associated with maternal nausea and vomiting, reduced uteroplacental perfusion, and adverse fetal acid-base changes. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/ml, continious ephedrine infusion at a rate of 30 ml/min and Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
27 Sep 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Healthy pregnant women,
  • American Society of Anesthesiologists (ASA) physical status I,
  • with an uncomplicated singleton pregnancy at ≥36 weeks of gestation, ●scheduled for elective Caesarean delivery under spinal anaesthesia.

Who cannot join

  • Pregnancy-induced hypertension or pre-eclampsia.
  • Chronic hypertension.
  • Cardiac disease.
  • Renal disease
  • Diabetes mellitus.
  • Multiple pregnancy.
Show all 14Show fewer
  • Known fetal anomaly.
  • Known fetal growth restriction or significant fetal compromise
  • Placenta previa/accreta or significant antepartum haemorrhage.
  • Contraindication to spinal anaesthesia.
  • Allergy or contraindication to any study medication.
  • Baseline maternal bradycardia.
  • Emergency Caesarean delivery.
  • Patients receiving medications likely to substantially affect maternal heart rate or blood pressure.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Medical Research Institute

    Alexandria, Alexandria Governorate

Other trials in Egypt

About this study

Official title: Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery: A Randomized Controlled Trial

Background Spinal anaesthesia is the preferred anaesthetic technique for most elective Caesarean deliveries; however, maternal hypotension following spinal anaesthesia remains very common and may be associated with maternal nausea and vomiting, reduced uteroplacental perfusion, and adverse fetal acid-base changes.

Several vasopressors have been used for the prevention and treatment of spinal anaesthesia-induced hypotension. Ephedrine has traditionally been used because of its combined α- and β-adrenergic effects. However, its indirect sympathomimetic action and placental transfer have raised concerns regarding maternal tachycardia and fetal metabolic effects.

Read more

Norepinephrine is a potent α-adrenergic agonist with modest β-adrenergic activity. It has increasingly been investigated as an alternative vasopressor for Caesarean delivery because it can effectively maintain maternal arterial pressure with less maternal tachycardia than ephedrine. Randomized studies comparing norepinephrine and ephedrine have demonstrated effective prevention of spinal hypotension with norepinephrine and, in some studies, more favourable neonatal acid-base variables.

Phenylephrine is widely used internationally for this indication; however, because of its limited availability in the Egyptian market, norepinephrine represents a potentially practical alternative in the local setting.

The present study is designed to compare prophylactic continuous infusions of norepinephrine, ephedrine, and a combination of norepinephrine and ephedrine for prevention of spinal anaesthesia-induced hypotension during elective Caesarean delivery. Maternal haemodynamic effects and neonatal outcomes, including umbilical cord blood gas analysis, will be assessed.

Aim of the study To compare the efficacy and safety of prophylactic continuous infusion of norepinephrine, ephedrine, and their combination in preventing spinal anaesthesia-induced hypotension during elective Caesarean delivery.

Primary outcome The incidence of maternal hypotension from initiation of spinal anaesthesia until delivery, defined as:Systolic blood pressure (SBP) <90 mmHg.

Secondary outcomes Maternal outcomes

  1. Number of hypotensive episodes.
  2. Duration of hypotension.
  3. Number of rescue vasopressor boluses required.
  4. Total dose of study vasopressor administered.
  5. Incidence of hypertension, defined as SBP >140 mmHg.
  6. Incidence of maternal bradycardia, defined as HR <50 beats/min.
  7. Incidence of nausea and vomiting.
  8. Incidence of shivering.

Neonatal outcomes Apgar score at 1 and 5 minutes. Umbilical arterial pH. Umbilical arterial PaCO₂. Umbilical arterial bicarbonate. Patients The study will include healthy pregnant women, American Society of Anesthesiologists (ASA) physical status I, with an uncomplicated singleton pregnancy at ≥36 weeks of gestation, scheduled for elective Caesarean delivery under spinal anaesthesia.

After approval by the institutional Ethics Committee and obtaining written informed consent, eligible patients will be randomly allocated in a 1:1:1 ratio to one of three groups using computer-generated randomization and sequentially numbered, opaque, sealed envelopes.

Group N - Norepinephrine Norepinephrine concentration: 4 µg/mL Group NE - Combination Norepinephrine concentration: 2 µg/mL plus Ephedrine concentration: 2 mg/mL Group E - Ephedrine Ephedrine concentration: 4 mg/mL Anaesthetic technique All patients will have an 18-G peripheral intravenous cannula inserted before transfer to the operating theatre.

On arrival in theatre, standard monitoring will be established, including ECG, non-invasive blood pressure, heart rate and pulse oximetry.

Baseline haemodynamic measurements After allowing the patient to rest in the operating theatre, three consecutive measurements of SBP and HR will be obtained before spinal anaesthesia at 1-minute intervals.

The mean of the final two measurements will be considered the patient's baseline SBP and HR.

This standardized pre-spinal baseline will be used for assessment of haemodynamic changes during the study.

Spinal anaesthesia will be performed with the patient in the sitting position at the L3-L4 or L4-L5 interspace using a 27-G Whitacre needle.

After free flow of cerebrospinal fluid has been established, 12.5 mg hyperbaric bupivacaine 0.5% with fentanyl 25 µg will be injected over approximately 10-15 seconds.

Immediately following the spinal injection, the patient will be positioned supine with approximately 15° left uterine displacement.

No routine fluid preload will be administered. Ringer's acetate solution will be administered at a minimal rate required to maintain intravenous access, with a maximum volume of 500 mL .

Haemodynamic measurements SBP and HR will be recorded at 1-minute intervals from the administration of spinal anaesthesia until delivery.

After delivery, measurements will be obtained at 2-minute intervals until completion of surgery.

The following variables will be recorded:

Baseline SBP and HR. Lowest SBP

Being tested
continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/ml, continious ephedrine infusion at a rate of 30 ml/min, Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/mlDrug

    prevention of maternal hypotension under spianl anaesthesia is very important , investigatiog the right dose and drug to prevent both maternal hypotension and fproptimum fetal outcome

  • continious ephedrine infusion at a rate of 30 ml/minDrug

    prevention of maternal hypotension under spianl anaesthesia is very important , investigatiog the right dose and drug to prevent both maternal hypotension and fproptimum fetal outcome

  • Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min.Drug

    prevention of maternal hypotension under spinal anesthesia is very important , investigatiog the right dose and drug to prevent both maternal hypotension and fproptimum fetal outcome

Study groups in NCT07899216
Study groupRoleWhat they receive
Norepinephrine group:continiuos infusion at 30 ml/hrActive comparatorThe dedicated infusion (400 µg norepinephrine diluted with normal saline to 50 mL → 8 µg/mL) will be infused at a fixed rate of at 30 ml/hr after the spinal anaesthesia
Receives: Drug: continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/ml
Ephedrine group: 4 mg /mlActive comparatorpatients will receive continious infusion of 4 mg/ml ephedriena at fixed rate of 30ml/min
Receives: Drug: continious ephedrine infusion at a rate of 30 ml/min
Combination group: 200 µg norepinephrine + 200 mg ephedrine diluted with normal saline to 50 mL →Active comparator200 µg norepinephrine + 200 mg ephedrine diluted with normal saline to 50 mL → 4 µg/mL norepinephrine + 4 mg/mL ephedrine.. at 30 ml/hr
Receives: Drug: Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of maternal hypotension from initiation of spinal anaesthesia until end of the opertation .

    The number of patients who develop hypotension (defined as decreased SBP less than 80% of the baseline reading during the period from intrathecal injection till delivery of the fetus) after spinal block divided by the total number in the group

    Measured: 60 min after the block

Secondary outcomes (10)
  1. 1-Number of hypotensive episodes

    The number of hypotensive episode experienced by each patient in each group

    Measured: 60 min after the block

  2. 2-Number of rescue vasopressor boluses required

    Number or rescue doses administrated to each patient when experiencing hypotension defined as SBP less than 80% of the baseline reading

    Measured: 60 min after the block

  3. 3-Incidence of hypertension

    number of patients who develop intraoperive hypertension (defined as increased systolic blood pressure by more than 20% of the baseline reading) divided by the total number of patients in the group

    Measured: 60 min after the block

  4. 4-Incidence of maternal bradycardia, defined as HR <50 beats/min

    number of patients who developed bradycardia, defined as HR <50 beats/min

    Measured: 60 min after the block

  5. 5-Incidence of nausea and vomiting

    number of patients who developed nausea and vomiting

    Measured: 60 in after the block

  6. 6-Incidence of shivering

    number of patients who developed shivering

    Measured: 60 in after the block

  7. 7- Any other maternal complications

    any other maternal complications will be spotted and recorded

    Measured: 60 min after the block

  8. 8-Apgar score

    APGAR score for detection of the well being of the neonate

    Measured: 1 and 5 minutes after the delivery of the baby

  9. 9-Umbilical arterial pH.

    PH of the blood sample withdrawn from the umbilical cord

    Measured: 1 min after the delivery

  10. 10-Umbilical arterial PaCO₂.

    PaCO2 of the blood sample withdrawn from the umbilical cord

    Measured: 1 min after the delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start27 Sep 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899216
Sponsor's protocol ID
Vasopressors in C-section
Status last verified
Sep 2026
First submitted
27 Sep 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: data , statistical analysis and the study protocol

Publications

  • Chen Y, Zou L, Li Z, Guo L, Xue W, He L, Ma S, Ni X. Prophylactic norepinephrine infusion for postspinal anesthesia hypotension in patients undergoing cesarean section: A randomized, controlled, dose-finding trial. Pharmacotherapy. 2021 Apr;41(4):370-378. doi: 10.1002/phar.2514. Epub 2021 Mar 5.

    PubMed 33583066
  • Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.

    PubMed 30335625

Questions about this trial

What is this clinical trial studying?

A study testing continuous infusion of noreadrenaline at a fixed rate of 30 ml/min of 4ug/ml, continious ephedrine infusion at a rate of 30 ml/min and Patients will receive a combined infusion of norepinephrine 2 µg/min and ephedrine 2 mg/min. in people with Maternal Hypotension After Spinal Anesthesia, run by Alexandria University at 1 site in Egypt.

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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

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?

The incidence of maternal hypotension from initiation of spinal anaesthesia until end of the opertation . (time frame: 60 min after the block). 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 NCT07899216, which also lists 2 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 27 Oct 2026.

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