Norepinephrine Versus Phenylephrine Continuous Variable Infusion for Prevention of Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Double-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 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 Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) 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, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.
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, Care Provider, 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-eclampsia
- •Eclampsia
- •Cardiac dysfunction
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. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
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. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
干预措施: Bupivacaine (Drug)
Norepinephrine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
干预措施: Norepinephrine (Drug)
Norepinephrine
Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.
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 severe delivery hypotension(10 minutes after delivery)
- Systolic blood pressure(2 hours after subarachnoid block)
- Heart rate(2 hours after subarachnoid block)
- APGAR score for assessment of the general state of the fetus(10 minutes after delivery)
- Incidence of reactive hypertension(2 hours after spinal anesthesia)
- Umbilical arterial potential hydrogen (PH)(10 minutes after delivery)
- Umbilical arterial Partial pressure of Carbon dioxide(10 minutes after delivery)
- incidence of nausea(2 hours)
- Incidence of vomiting(2 hours)
- Total phenylephrine consumption(2 hours)
- Total norepinephrine consumption(2 hours)
- Total ephedrine consumption(2 hours)
研究者
Ahmed Hasanin
Assistant professor
Cairo University