ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Volume of HES which will prevent hypotension if 50 % of the subjects.
研究概览
简要总结
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal anesthesia.
详细描述
The incidence of spinal anesthesia-induced hypotension in pregnant women undergoing a cesarean section is high. A preoperative fluid bolus of undetermined volume is frequently administered to lower the incidence of maternal hypotension, with a somewhat poor efficacy. Recently, several investigations have shown that the use of a phenylephrine infusion after the induction of spinal anesthesia results in a significant reduction in hypotensive episodes. Given the high efficacy of this therapy (incidence of hypotension around 20%), it is possible to determine the effective volume of fluid which would prevent hypotension in 50% of the patients studied (ED50).
Healthy term pregnant women undergoing elective cesarean section under spinal anesthesia will be recruited in this trial. The spinal anesthesia regimen will be standardized and all subjects will receive a phenylephrine infusion. The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)). The ED50 will be determined using an up-down sequential allocation method initially described by Dixon & Massey. The determination of the HES ED50 will help the anesthesiologist in further treating maternal hypotension appropriately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnant women (ASA I or II)
- •Normal pregnancy
- •Term gestation (37 weeks and above)
- •Elective cesarean section
- •Spinal anesthesia
排除标准
- •Cardiopathies
- •Hypertensive disease/ pre-eclampsia / eclampsia
- •Any contraindication to neuraxial anesthesia
- •Patient refusal
- •Body mass index > 30 at first antenatal visit and > 32 at cesarean section
- •Twin pregnancy
- •Known allergies to HES
- •Emergency cesarean section
研究组 & 干预措施
Hydroxyethylstarch 130/0.4
干预措施: Hydroxyethylstarch 130/0.4 (Drug)
结局指标
主要结局
Volume of HES which will prevent hypotension if 50 % of the subjects.
时间窗: 4 months
次要结局
- Incidence of hypotension episodes(1 hour)
- Incidence of hypertensive episodes(1 hour)
- cardiac output(1 hour)
- Apgar score(10 minutes)
- umbilical artery pH(2 hours)
- additional vasopressors administered(1 hour)
研究者
Christian Loubert
Dr
Maisonneuve-Rosemont Hospital