Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative maternal hypotension
研究概览
简要总结
160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
详细描述
After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
At the end of the study all collected data will use for statistically analysis.
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 (Participant, Care Provider)
盲法说明
Partipicants and care providers will not known which medication will apply.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I-II physical status
- •Pregnant patients
- •Full term pregnant
排除标准
- •ASA III-IV physical status
- •Emergency status
- •Heart disease
- •Hypertension
- •Body mass index>25
研究组 & 干预措施
Epinephrine
Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.
干预措施: Epinephrine (Drug)
Norepinephrine
Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h.
干预措施: Norepinephrine (Drug)
Phenylephrine
Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.
干预措施: Phenylephrine (Drug)
Control
Saline infusion will apply at equivalent volume till the surgical operation
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of intraoperative maternal hypotension
时间窗: At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.
The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP \<90 mm Hg), the total number of hypotension episodes during surgery
次要结局
未报告次要终点