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NCT Number: NCT07379710

Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery

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

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Key information

Conditions

Incidence of Post-spinal Hypotension

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status II
  • Age: 18 to 40 years
  • Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.

Exclusion criteria

  • 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.

Treatment and study plan

Ephedrine and Norepinephrine infusion

Drug

Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min

Norepinephrine infusion

Drug

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

Primary outcomes

  1. Incidence of post-spinal hypotension

    Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

Secondary outcomes

  1. Incidence of bradycardia

    Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

    Defined as heart rate < 55 bpm

  2. Reactive hypertension

    Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

    Defined as SBP > 120% from the baseline reading

  3. Systolic blood pressure

    Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  4. Heart rate

    Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

  5. Rescue vasopressor consumption

    Time frame: Just after spinal anaesthesia until delivery of the fetus

    Cumulative intraoperative boluses of ephedrine and norepinephrine doses

  6. Neonatal outcomes Apgar Score

    Time frame: Within 5 minutes of baby delivery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Islam Reda, Lecturer

CONTACT

[email protected]

+201003315095

Mohamed AMY AMY Ollaek, Assistant Professor

CONTACT

[email protected]

+20100 659 5598

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.