A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
研究概览
简要总结
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.
详细描述
On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.
After spinal block, patients will be randomly allocated into one of two groups:
- Phenylephrine group (n=100)
- Norepinephrine group (n=100)
Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •full term singleton parturients
- •elective cesarean sections
排除标准
- •cardiac morbidities
- •hypertensive disorders of pregnancy
- •peripartum bleeding
- •body mass index > 35 will be excluded from the study
研究组 & 干预措施
phenylephrine,
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
干预措施: phenylephrine (Drug)
phenylephrine,
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
干预措施: Bupivacaine (Drug)
phenylephrine,
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
干预措施: Fentanyl (Drug)
phenylephrine,
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
干预措施: Placebo (normal saline) (Drug)
norepinephrine
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
干预措施: Norepinephrine (Drug)
norepinephrine
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
干预措施: Bupivacaine (Drug)
norepinephrine
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
时间窗: 2 hours
次要结局
- nausea and vomiting measured in number of attacks(2 hours)
- heart rate measured in beats per minute(2 hours)
- systolic and diastolic blood pressures measured in mm Hg(2 hours)
研究者
ahmed elsakka
Principal investigator and lecturer of anesthesia, faculty of medicine cairo university
Kasr El Aini Hospital