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.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Incidence of post-spinal hypotension
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status II
- •Age: 18 to 40 years
- •Undergoing Elective Lower Segment Cesarean Section under Spinal Anesthesia.
排除标准
- •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.
研究组 & 干预措施
Group(A)
Ephedrine 10 mg (2.5mg/ml) direct I.V will be given simultaneous with Norepinephrine infusion 0.08 mcg/kg/min
干预措施: Ephedrine and Norepinephrine infusion (Drug)
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
干预措施: Norepinephrine infusion (Drug)
结局指标
主要结局
Incidence of post-spinal hypotension
时间窗: Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus
次要结局
- Incidence of bradycardia(Baseline (T0), just after spinal anaesthesia (T1) then every 2.5 minutes until delivery of the fetus)
- Reactive hypertension(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(Just after spinal anaesthesia until delivery of the fetus)
- Neonatal outcomes Apgar Score(Within 5 minutes of baby delivery)
研究者
Mohamed Youssef
Assistant Professor
Cairo University