Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ephedrine and Norepinephrine infusion, Norepinephrine infusion.
- Who it may be relevant to
- Registry conditions: Incidence of Post-spinal Hypotension. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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
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.
Interventions
- 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 - 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
Primary outcome measures
- 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 outcome measures (6)
- Incidence of bradycardia [Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus]
- Reactive hypertension [Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus]
- Systolic blood pressure [Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus]
- Heart rate [Time frame: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus]
- Rescue vasopressor consumption [Time frame: Just after spinal anaesthesia until delivery of the fetus]
- Neonatal outcomes Apgar Score [Time frame: Within 5 minutes of baby delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Egypt · 1 center
- Faculty of Medicine, Cairo University, Cairo — Cairo
Identifiers
NCT: NCT07379710 · MS-528-2023