Role of Norepinephrine Infusion in Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- throracic volume variations change from baseline
研究概览
简要总结
This study will be conducted on 40 healthy women having spinal anesthesia for elective cesarean delivery in the operating rooms at Menoufia university hospital.
详细描述
Informed written consent will be taken from all subjects included in the study after approval of the study by the local ethical committee.
All subjects will be subjected to thorough history taking with risk factors, medical histories, general clinical examination, local clinical examination, laboratory investigations as complete blood count and coagulation profile.
Standardized anesthetic care will be provided according to institutional standards, which include fasting, antacid premedication and noninvasive hemodynamic monitoring After arrival in the operating room, patients will be positioned supine with left lateral tilt, pulse oximeter, ECG leads, non-invasive blood pressure cuff and cardiometry leads (4 surface ECG electrodes is attached to the left side of the neck and the lower thorax (approximately at the level of the xiphoid process) will be attached to patient for monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance and values will be recorded as a baseline and every 10 minutes after intrathecal injection.
10 ml/kg/hr lactated ringer solution will be infused to all patients through an 18 gauge intravenous cannula for 30 minutes as a preload before spinal anesthesia then reduced to maintenance infusion of 6 ml/kg/hr.
Patients will be then placed in sitting position. After skin disinfection and skin infiltration with lidocaine 1%, spinal anesthesia will be performed with 2ml 0.5% hyperbaric bupivacaine (10 mg) in addition to 0.5 ml fentanyl (25 μg) at L3-L4 or L4-L5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I & II
- •Non laboring
- •Normotensive
- •Elective cesarean delivery under spinal anesthesia.
- •Baseline systolic blood pressure 90-140 mm Hg
排除标准
- •Known fetal abnormality.
- •Preexisting or pregnancy-induced hypertension.
- •Known cardiovascular or cerebrovascular disease.
- •Thrombocytopenia, coagulopathy or any contraindication to spinal anesthesia.
- •Weight <50 or >100 kg, height <140 or >180 cm.
- •Inability or refusal to give informed consent
研究组 & 干预措施
infusion
patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline
干预措施: cardiometry (Device)
infusion
patients will receive an infusion of norepinephrine that will be started at 2.5μg/min immediately after intrathecal injection and then manually adjusted according to monitoring of blood pressure (bp), heart rate, fluid responsiveness (thoracic volume variations and stroke volume variations), cardiac index and systemic vascular resistance by using cardiometry, with the objective of maintaining values near baseline
干预措施: Norepinephrine infusion (Drug)
bolus
patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value.
干预措施: Norepinephrine bolus (Drug)
bolus
patient with no prophylactic vasopressor and a bolus of 5 μg norepinephrine will be given whenever systolic BP decreases to <80% of the baseline value.
干预措施: cardiometry (Device)
结局指标
主要结局
throracic volume variations change from baseline
时间窗: every 10 minutes up to 1 hour
using cardiometry
cardiac index change from baseline
时间窗: every 10 minutes up to 1 hour
using cardiometry
systemic vascular resistance change from baseline
时间窗: every 10 minutes up to 1 hour
using cardiometry
stroke volume variation change from baseline
时间窗: every 10 minutes and up to 1 hour
using cardiometry
次要结局
- umblical cord gases sample(in the first minute after delivery)
- APGAR score(after 5 minutes and 10 minutes after delivery)
- Non invasive MEAN blood pressure(every 10 minutes and up tp 1 hour)
- Heart rate(every 10 minutes and up to 1 hour)
研究者
mostafa saieed fahim mansour
lecturer
Menoufia University