NCT01216410已完成不适用
The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Intraoperative Nausea and Vomiting
研究概览
简要总结
The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking ASA I-II non-laboring women with single gestations ≥36 weeks
- •Scheduled or unscheduled cesarean delivery under spinal anesthesia
- •Height: 5 feet-5 feet 11 in.
排除标准
- •Laboring women needing an emergency cesarean delivery
- •Subjects less than 18 years of age
- •Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section
- •Allergy to ondansetron, or metoclopramide
- •Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria.
- •Severe Cardiac disease in pregnancy with marked functional limitations
- •Diabetes type I
- •Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- •Morbid obesity (body mass index (BMI)>45)
- •Inclusion in another anesthetic study involving drug administration
研究组 & 干预措施
Metoclopramide
Active Comparator
Prophylaxis with metoclopramide and phenylephrine infusion.
干预措施: Metoclopramide (Drug)
Phenylephrine infusion
Placebo Comparator
Prophylactic phenylephrine infusion and placebo antiemetics
干预措施: Phenylephrine infusion (Drug)
Combination Group
Active Comparator
Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion
干预措施: Combination Group (Drug)
结局指标
主要结局
Intraoperative Nausea and Vomiting
时间窗: Intraoperatively
Comparison of intraoperative nausea and vomiting between the 3 groups.
次要结局
- Pruritus(0-24 hrs)
- Postoperative Nausea and Vomiting (PONV)(0-2h, 2-6h, 6-24h)
- Satisfaction(24 h)
- Maternal Hemodynamics(Intraoperatively)
研究者
研究点 (1)
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