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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Incidence of Post-spinal Hypotension
• Intervention / Treatment: Drug: Ephedrine and Norepinephrine infusion; Drug: Norepinephrine infusion

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.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohamed AMY AMY Ollaek, Assistant Professor; Phone Number: +20100 659 5598; Email: ollaekm@kasralainy.edu.eg
• Study Contact Backup: Name: Islam Reda, Lecturer; Phone Number: +201003315095; Email: islam.reda@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of Medicine, Cairo University, Cairo
    • Contact: Mohamed AMY AMY Ollaek, Assistant Professor; Phone Number: +20100 659 5598; Email: ollaekm@kasralainy.edu.eg
    • Contact: Islam Reda, Lecturer; Phone Number: +201003315095; Email: islam.reda@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group(A); Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min	Drug: Ephedrine and Norepinephrine infusion; Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min
Active Comparator: Group (B); 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	Drug: Norepinephrine infusion; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of post-spinal hypotension	Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of bradycardia	Defined as heart rate < 55 bpm	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	Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Systolic blood pressure		Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
Heart rate		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	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	Within 5 minutes of baby delivery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed A Ollaek, MD, Faculty of Medicine, Cairo University, Cairo

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Amines; Alcohols; Propanolamines; Amino Alcohols; Propanols; Phenethylamines; Ethylamines; Ephedrine
• Other Study ID Numbers: MS-528-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No