Prophylactic Norepinephrine Infusion Combined With 6% Hydroxyethyl Starch (130/0.4) Coload for Postspinal Anesthesia Hypotension in Patients Undergoing Cesarean Section: A Randomized, Controlled, Dose-finding Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- The incidence of post-spinal anesthesia hypotension
研究概览
简要总结
The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
详细描述
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine with colloid coload is still unknown. The purpose of this study is to investigate the suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing cesarean section.
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
- Double (Participant, Investigator)
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
- •18-40 years
- •Primipara or multipara
- •Singleton pregnancy ≥ 37 weeks
- •American Society of Anesthesiologists physical status classification I to II
- •Scheduled for elective cesarean section under spinal anesthesia
排除标准
- •Body height < 150 cm
- •Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
- •Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
- •Hemoglobin < 7g/dl
- •Coagulation or renal function disorders
- •Known allergy to hydroxyethyl starch
- •Fetal distress, or known fetal developmental anomaly
研究组 & 干预措施
Control group
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.
干预措施: Normal saline (Drug)
0.025 μg/kg/min group
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.025 μg/kg/min) by IV infusion.
干预措施: Norepinephrine (0.025 μg/kg/min) (Drug)
0.05 μg/kg/min group
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.05 μg/kg/min) by IV infusion.
干预措施: Norepinephrine (0.05 μg/kg/min) (Drug)
0.075 μg/kg/min group
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.075 μg/kg/min) by IV infusion.
干预措施: Norepinephrine (0.075 μg/kg/min) (Drug)
0.1μg/kg/min group
Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of norepinephrine (0.1μg/kg/min) by IV infusion.
干预措施: Norepinephrine (0.1 μg/kg/min) (Drug)
结局指标
主要结局
The incidence of post-spinal anesthesia hypotension
时间窗: 1-15 minutes after spinal anesthesia
Systolic blood pressure (SBP) \< 80% of the baseline
次要结局
- The incidence of severe post-spinal anesthesia hypotension.(1-15 minutes after spinal anesthesia)
- The incidence of hypertension.(1-15 minutes after spinal anesthesia)
- Concentration of base excess(Immediately after fetal delivery)
- Apgar score (0-10; a higher score means a better outcome)(5 min after fetal delivery)
- The incidence of bradycardia.(1-15 minutes after spinal anesthesia)
- Partial pressure of oxygen(Immediately after fetal delivery)
- Overall stability of systolic blood pressure control versus baseline(1-15 minutes after spinal anesthesia)
- The incidence of nausea and vomiting.(1-15 minutes after spinal anesthesia)
- pH value(Immediately after fetal delivery)
- Apgar score (0-10;a higher score means a better outcome)(5 min after fetal delivery)