Comparing 10- Versus 15-mcg Norepinephrine Bolus for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- the incidence of successful management of severe post-spinal hypotension
研究概览
简要总结
Data regarding the optimum dose of norepinephrine for management of severe maternal hypotension is lacking. A previous report showed that the use of 10-mcg norepinephrine bolus was not superior to the 5-mcg bolus in the management of severe hypotension in addition the incidence of reactive bradycardia and hypertension was comparable in the two doses. Therefore, we hypothesize that using a higher dose of norepinephrine (15 mcg) would increase the success rate of management of severe hypotensive episode.
详细描述
Upon arrival to the operating room, the patient will be in supine position with left uterine displacement using a wedge below the right buttock. Routine monitoring will be applied (electrocardiography, pulse oximetry, and non-invasive blood pressure monitor). An 18G-cannula will be inserted, and the patients will receive 10 mg metoclopramide. Baseline heart rate and systolic blood pressure will be recorded as the average of three consecutive readings with 2-minutes interval.
Lactated Ringer's solution will be infused at rate of 15 mL/Kg over 10 minutes as a co-load; spinal anesthesia will be achieved by injecting 10 mg of hyperbaric bupivacaine and 20 mcg fentanyl into the subarachnoid space at L3-L4 or L4-L5 interspace using 25G spinal needle.
After subarachnoid block, mothers will be placed in the supine position with left-lateral tilt.
Block success will be assessed after 5 minutes from intrathecal injection of local anesthetic; and will be confirmed if sensory block level is at T4.
The patient would receive the study drug only if she developed severe post-spinal hypotension (defined as systolic blood pressure ≤60% of the baseline reading) as her first hypotensive episode. The management of the hypotensive episode will be considered successful if the systolic blood pressure is > 80% of the baseline within 2 mins of the bolus. If the bolus failed, norepinephrine bolus of 5 mcg will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •full-term singleton pregnant women
- •American society of anesthesiologist II, scheduled for elective cesarean delivery,
排除标准
- •Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction < 50%, heart block, and arrhythmias),
- •hypertensive disorders of pregnancy,
- •peripartum bleeding,
- •coagulation disorders (patients with INR >1.4 and or platelet count < 80000 /dL) or any contraindication to regional anesthesia,
- •baseline systolic blood pressure (SBP) < 100 mmHg
研究组 & 干预措施
10 mcg group
patient will receive the study dry once developed severe post-spinal hypotension
干预措施: 10 mcg Norepinephrine (Drug)
15 mcg group
patients will receive the study dry once developed severe post-spinal hypotension
干预措施: 15 mcg Norepinephrine (Drug)
结局指标
主要结局
the incidence of successful management of severe post-spinal hypotension
时间窗: 1 min after spinal anesthesia until 5 min after the delivery
systolic blood pressure \>80% of baseline after drug bolus
次要结局
- umbilical blood pH(5 min after delivery)
- heart rate(baseline, 1 min after spinal anesthesia until 5 min after the delivery)
- reactive bradycardia(1 min after spinal anesthesia until 5 min after the delivery)
- systolic blood pressure(baseline, 1 min after spinal anesthesia until 5 min after the delivery)
- time to severe hypotensive episode(1 min after spinal anesthesia until 5 min after the delivery)
- reactive hypertension(1 min after spinal anesthesia until 5 min after the delivery)
- Apgar score(5 min after delivery)
研究者
Ahmed Hasanin
Principal Investigator
Cairo University