Comparison of Two Vasopressor Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- incidence of post-spinal anesthesia hypotension
研究概览
简要总结
Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against Post-spinal hypotension during cesarean delivery.
详细描述
Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.
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
- 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
- •full term
- •pregnant women
- •scheduled for cesarean section
排除标准
- •pre-ecpamsia
- •eclampsia
- •cardiac dysfuction
研究组 & 干预措施
Phenylephrine
Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
干预措施: Phenylephrine (Drug)
Phenylephrine
Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
干预措施: Bupivacaine (Drug)
Norepinephrine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
干预措施: Norepinephrine (Drug)
Norepinephrine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure
干预措施: Bupivacaine (Drug)
结局指标
主要结局
incidence of post-spinal anesthesia hypotension
时间窗: 30 minutes after spinal anesthesia
Defined as the percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading
次要结局
- incidence of severe post-spinal anesthesia hypotension(30 minutes after spinal anesthesia)
- incidence of reactive hypertension(2 hours after spinal anesthesia)
- incidence of severe delivery hypotension(10 minutes after delivery)
- heart rate(2 hours after subarachnoid block)
- APGAR score(10 minutes after delivery)
- systolic blood pressure(2 hours after subarachnoid block)
- diastolic blood pressure(2 hours after subarachnoid block)
研究者
Ahmed Hasanin
Assistant professor
Cairo University