Hemodynamic (MAP) StabilityPhase 3NCT07480889
Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section
A Phase 3 study testing Epinephrine (Adrenaline) bolus then infusion and Epinephrine (Adrenaline) infusion in people with Hemodynamic (MAP) Stability, run by Cairo University at 1 site in Egypt.
Trial summary
In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Hemodynamic (MAP) Stability
- What is being tested?
- Epinephrine (Adrenaline) bolus then infusion and Epinephrine (Adrenaline) infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2026to 3 Aug 2026
- Phase
- Phase 3
- 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 35 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.
Who cannot join
- Uncontrolled cardiac morbidities as reduction of ejection fraction< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents
- Poorly controlled Hypertensive disorders of pregnancy
- Peripartum bleeding
- Multiple pregnancies (e.g., twin gestations)
- Coagulation disorders defined as platelet count <100,000/μL, INR >1.4, or known inherited clotting factor deficiency.
- Baseline systolic blood pressure (SBP) < 100 mmHg or >130 mmHg
- Refusal of patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial
In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Phenylephrine infusion is an important therapeutic strategy for preventing spinal-induced hypotension (SIH) in cesarean delivery, as it decreases the incidence of hypotension, nausea, and vomiting. However, high doses may reduce maternal heart rate and cardiac output in a dose-dependent manner.
Ephedrine, previously considered the first-choice drug, has both α and β receptor agonistic activity and causes norepinephrine release from sympathetic neurons. Its β1 effect increases heart rate and contractility, but may cause undesirable tachycardia. Tachyphylaxis can develop with repeated doses. Norepinephrine, the biosynthetic precursor of epinephrine, has both potent α and weak β agonist effects, tending to cause bradycardia.
Read more
Despite a lower incidence of hypotension with prophylactic norepinephrine, PSH still occurs in up to 30% of parturients undergoing cesarean section. The administration of a bolus dose of epinephrine prior to continuous infusion is an unusual practice in obstetric anesthesia, but has been reported to be safe in other contexts and in pregnant women when used for hemodynamic support.
Epinephrine has both potent α- and β-adrenoceptor agonist activity. Its β effects could offset reflex decreases in maternal HR and CO during spinal anesthesia for cesarean delivery. Although some studies compared epinephrine infusion with phenylephrine, it remains unclear whether adding an initial bolus of epinephrine before infusion offers superior maternal hemodynamic stability compared to infusion alone.
- Conditions
- Hemodynamic (MAP) Stability
- Being tested
- Epinephrine (Adrenaline) bolus then infusion, Epinephrine (Adrenaline) infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine (Adrenaline) bolus then infusionDrug
A bolus of 4 mcg epinephrine will be given just after spinal anaesthesia followed by 0.03 mcg/kg/min infusion which is equivalent to 1.8 mcg/kg/hr. Epinephrine dose of 3000 mcg will be diluting in 500 mL saline (6 mcg/mL), and the infusion rate will be set on 0.3 mL/kg/hr.
Epinephrine (Adrenaline) infusionDrug
Patients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus.
| Study group | Role | What they receive |
|---|---|---|
| Bolus plus infusion group | Active comparator | Not described Receives: Drug: Epinephrine (Adrenaline) bolus then infusion |
| Infusion group | Active comparator | Not described Receives: Drug: Epinephrine (Adrenaline) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal hypotension
defined as systolic blood pressure drop >20% from baseline, measured from block onset until 5 minutes after delivery
Measured: up to 2 hours after spinal anesthesia
Secondary outcomes (9)
Incidence of severe post-spinal hypotension
systolic blood pressure drop >30% from baseline or systolic blood pressure<80 mmHg
Measured: up to 2 hours after spinal anaesthesia
Number of hypotensive and severe hypotensive episodes per patient
Measured: up to 2 hours after spinal anaesthesia
Incidence of reactive hypertension (systolic blood pressure ≥ 120% of baseline)
Measured: up to 2 hours after spinal anaesthesia
Number of reactive hypertension episodes per patient
Measured: up to 2 hours after spinal anaesthesia
Incidence of tachycardia (heart rate >130% baseline, not related to hypotension)
Measured: up to 2 hours after spinal anaesthesia
Incidence of intraoperative nausea and vomiting
Measured: up to 2 hours after spinal anesthesia
Total intraoperative norepinephrine consumption
Measured: up to 2 hours after spinal anaesthesia
Fetal outcomes: umbilical artery blood gases
Umbilical artery blood gases obtained after delivery at 1 and 5 minutes
Measured: up to 5 minutes after fetal delivery
• Fetal outcomes: Apgar scores
Apgar scores at 1 and 5 minutes after delivery
Appearance (Skin color: 0=Blue/Pale, 1=Pink body/blue limbs, 2=All pink) Pulse (Heart rate: 0=None, 1=<100 bpm, 2=>100 bpm) Grimace (Reflex irritability: 0=None, 1=Grimace, 2=Cry/vigorous reaction) Activity (Muscle tone: 0=Limp, 1=Some flexion, 2=Active motion) Respiration (Breathing: 0=None, 1=Weak/irregular, 2=Strong cry)
Interpretation:
7-10: Normal (reassuring). 4-6: Fair/Abnormal (may require stimulations or oxygen). 0-3: Low/Critically low (indicates need for intensive resuscitation).
Measured: up to 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start18 Mar 2026
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic (MAP) StabilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480889
- Sponsor's protocol ID
- MS-572-2025
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding a Low-Dose Epinephrine Bolus Prior to Infusion on Maternal Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07480889
- Acronym / sponsor ID
- MS-572-2025
- Conditions
- Hemodynamic (MAP) Stability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 18 Mar 2026 (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.
In North America, norepinephrine, ephedrine, and epinephrine have been recommended as first-choice vasopressors for the treatment of spinal hypotension during cesarean delivery. However, in international consensus guidelines, epinephrine was recommended for circulatory collapse only. Phenylephrine infusion is an important therapeutic strategy for preventing spinal-induced hypotension (SIH) in cesarean delivery, as it decreases the incidence of hypotension, nausea, and vomiting. However, high doses may reduce maternal heart rate and cardiac output in a dose-dependent manner.
Ephedrine, previously considered the first-choice drug, has both α and β receptor agonistic activity and causes norepinephrine release from sympathetic neurons. Its β1 effect increases heart rate and contractility, but may cause undesirable tachycardia. Tachyphylaxis can develop with repeated doses. Norepinephrine, the biosynthetic precursor of epinephrine, has both potent α and weak β agonist effects, tending to cause bradycardia.
Despite a lower incidence of hypotension with prophylactic norepinephrine, PSH still occurs in up to 30% of parturients undergoing cesarean section. The administration of a bolus dose of epinephrine prior to continuous infusion is an unusual practice in obstetric anesthesia, but has been reported to be safe in other contexts and in pregnant women when used for hemodynamic support.
Epinephrine has both potent α- and β-adrenoceptor agonist activity. Its β effects could offset reflex decreases in maternal HR and CO during spinal anesthesia for cesarean delivery. Although some studies compared epinephrine infusion with phenylephrine, it remains unclear whether adding an initial bolus of epinephrine before infusion offers superior maternal hemodynamic stability compared to infusion alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus plus infusion group | Active comparator | Drug: Epinephrine (Adrenaline) bolus then infusion |
| Infusion group | Active comparator | Drug: Epinephrine (Adrenaline) infusion |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18 to 35 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.
Key exclusion criteria (7 listed)
- Uncontrolled cardiac morbidities as reduction of ejection fraction< 60%, History (within 3months) of myocardial infarction, cerebrovascular accident, transient ischemic attacks or coronary artery disease/stents
- Poorly controlled Hypertensive disorders of pregnancy
- Peripartum bleeding
- Multiple pregnancies (e.g., twin gestations)
- Coagulation disorders defined as platelet count <100,000/μL, INR >1.4, or known inherited clotting factor deficiency.
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 |
|---|---|---|
| Epinephrine (Adrenaline) bolus then infusionA bolus of 4 mcg epinephrine will be given just after spinal anaesthesia followed by 0.03 mcg/kg/min infusion which is equivalent to 1.8 mcg/kg/hr. Epinephrine dose of 3000 mcg will be diluting in 500 mL saline (6 mcg/mL), and the infusion rate will be set on 0.3 mL/kg/hr. | Drug | Bolus plus infusion group |
| Epinephrine (Adrenaline) infusionPatients will receive the epinephrine infusion dose of 0.03 mcg/Kg/min (6) immediately without the bolus. | Drug | Infusion group |
Primary outcome
Incidence of post-spinal hypotension
Time frame: up to 2 hours after spinal anesthesia
defined as systolic blood pressure drop >20% from baseline, measured from block onset until 5 minutes after delivery
9 secondary outcomes
Incidence of severe post-spinal hypotension
Time frame: up to 2 hours after spinal anaesthesia
Number of hypotensive and severe hypotensive episodes per patient
Time frame: up to 2 hours after spinal anaesthesia
Incidence of reactive hypertension (systolic blood pressure ≥ 120% of baseline)
Time frame: up to 2 hours after spinal anaesthesia
Number of reactive hypertension episodes per patient
Time frame: up to 2 hours after spinal anaesthesia
Incidence of tachycardia (heart rate >130% baseline, not related to hypotension)
Time frame: up to 2 hours after spinal anaesthesia
Incidence of intraoperative nausea and vomiting
Time frame: up to 2 hours after spinal anesthesia
Total intraoperative norepinephrine consumption
Time frame: up to 2 hours after spinal anaesthesia
Fetal outcomes: umbilical artery blood gases
Time frame: up to 5 minutes after fetal delivery
• Fetal outcomes: Apgar scores
Time frame: up to 5 minutes after delivery
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 28 Aug 2026.
Related trials for Hemodynamic (MAP) Stability
Enrolling by invitationObservational study
Unilateral Spinal vs General Anaesthesia in Low EF Patients: A Hemodynamic Comparison
Hemodynamic (MAP) Stability
Recruiting
Hemodynamic Optimization Using an Artificial Intelligenze System
Hemodynamic (MAP) Stability, Fluid Management
Not yet recruiting
Using Artificial Intelligence to Guide Fluid Therapy During Major Cancer Surgery: A Randomized Controlled Trial
Neoplasm, Cancer
Recruiting
Delta Variation to Guide Hemodynamic Optimization
Hemodynamic MAP Stability
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epinephrine (Adrenaline) bolus then infusion and Epinephrine (Adrenaline) infusion in people with Hemodynamic (MAP) Stability, run by Cairo 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 7 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 28 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of post-spinal hypotension (time frame: up to 2 hours after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2026.