Incidence of Post-spinal HypotensionPhase 4NCT07379710
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
A Phase 4 study testing Ephedrine and Norepinephrine infusion and Norepinephrine infusion in people with Incidence of Post-spinal Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
We hypothesize that the addition of ephedrine to norepinephrine infusion could decrease the incidence of post spinal hypotension(PSH) in parturient undergoing C.S under spinal anesthesia and minimize the changes in heart rate Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Incidence of Post-spinal Hypotension
- What is being tested?
- Ephedrine and Norepinephrine infusion and Norepinephrine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to Feb 2027
- Phase
- Phase 4
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status II
- Age: 18 to 40 years
- 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
- Coagulation disorders
- Baseline systolic blood pressure (SBP) < 100 mmHg
- Refusal of patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University, Cairo
Cairo, 11562
Mohamed AMY AMY Ollaek, Assistant Professor, +20100 659 5598, ollaekm@kasralainy.edu.eg
Islam Reda, Lecturer, +201003315095, islam.reda@kasralainy.edu.eg
About this study
Official title: Concomitant Use of Norepinephrine With Ephedrine Versus Norepinephrine Alone to Maintain Arterial Blood Pressure During Spinal Anesthesia for Cesarean Delivery, a A Prospective Double-blinded Study.
We hypothesize that the addition of ephedrine to norepinephrine infusion could decrease the incidence of post spinal hypotension(PSH) in parturient undergoing C.S under spinal anesthesia and minimize the changes in heart rate
Read the detailed description
Aim of the work: To compare between concomitant use of norepinephrine infusion with ephedrine versus use of norepinephrine infusion alone on maternal B.P following induction of spinal anaesthesia for C.S delivery.
Statistical analysis Sample Size: Our primary outcome is the incidence of post-spinal hypotension. In a previous study incidence of post spinal hypotension in the noradrenaline group was 32%. We calculated a sample size that could detect at least 50% difference between study groups. Using MedCalc Software version 14 (MedCalc Software bvba, Ostend, Belgium), a sample size of 246 patients will be needed to have a study power of 80% and alpha error of 0.05. The number was increased to be 260 envelopes (130 envelopes per group) to compensate for possible dropouts.
Statistical analysis:
Analysis of data will be performed using Statistical package for social science (SPSS) software, version 26 for Microsoft Windows (SPSS Inc., Chicago, iL, USA). Categorical data will be reported as frequency and percentages and will be analyzed using chi-squared test. Continuous data will be checked for normality using Kolmogorov-Smirnov test. Normally distributed data will be presented as means ±standard deviations and will be analyzed using unpaired student t-test.
Skewed data will be expressed as medians(quartiles) and will be analyzed using Mann Whitney U test. A two-way repeated measures ANOVA will be used to evaluate dose (between-groups factor) and time (repeated measures)". P value of 0.05 or less will be considered significant.
- Conditions
- Incidence of Post-spinal Hypotension
- Being tested
- Ephedrine and Norepinephrine infusion, Norepinephrine infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ephedrine and Norepinephrine infusionDrug
Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min
Norepinephrine infusionDrug
4 ml normal saline direct I.V will be given simultaneous with norepinephrine (to keep blinding) Infusion 0.08 mcg/kg/min only be infused
| Study group | Role | What they receive |
|---|---|---|
| Group(A) | Active comparator | Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min Receives: Drug: Ephedrine and Norepinephrine infusion |
| Group (B) | Active comparator | 4 ml normal saline direct I.V will be given simultaneous with norepinephrine (to keep blinding) Infusion 0.08 mcg/kg/min only be infused Receives: Drug: Norepinephrine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal hypotension
Measured: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Secondary outcomes (6)
Incidence of bradycardia
Defined as heart rate < 55 bpm
Measured: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Reactive hypertension
Defined as SBP > 120% from the baseline reading
Measured: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Systolic blood pressure
Measured: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Heart rate
Measured: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Rescue vasopressor consumption
Cumulative intraoperative boluses of ephedrine and norepinephrine doses
Measured: Just after spinal anaesthesia until delivery of the fetus
Neonatal outcomes Apgar Score
The Apgar score comprises five components: 1- color, 2- heart rate, 3- reflexes, 4- muscle tone, and 5- respiration, each of which is given a score of 0, 1, or 2
Measured: Within 5 minutes of baby delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence of Post-spinal HypotensionStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Youssef, Cairo University
- Investigators
- Mohamed A Ollaek, MD, Principal investigator, Faculty of Medicine, Cairo University, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379710
- Sponsor's protocol ID
- MS-528-2023
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No