A Double Blind Randomized Controlled Trial of Phenylephrine for the Prevention of Spinal Induced Hypotension in Obese Parturients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Incidence of Nausea and Vomiting
研究概览
简要总结
Previous research regarding the use of phenylephrine has excluded obese subjects (BMI >35). This subgroup of patients represents a large portion of the obstetric patient population locally and nationally. It is unclear whether previous research should be extrapolated to the obese patient population. This study is being done to compare the incidence of hypotension, intraoperative nausea and vomiting, and neonatal acidosis between obese patients who receive a prophylactic phenylephrine infusion versus those who receive phenylephrine boluses for the treatment of established hypotension. This study will help us determine whether using a phenylephrine infusion or a phenylephrine bolus is the best way to prevent/treat spinal induced hypotension during cesarean deliveries in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •ASA Physical Status I-II
- •Non-laboring women
- •Single gestations ≥ 36 weeks
- •Obese women (Body Mass Index 35 - 55 kg/m2)
- •Non-emergent CD under spinal anesthesia
排除标准
- •Height < 5'0"
- •Antiemetic drug use in the 24 hours prior to CD
- •Allergy to phenylephrine, or any other standardized medication
- •Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia)
- •Chronic hypertension receiving antihypertensive treatment
- •Severe Cardiac disease in pregnancy with marked functional limitations
- •Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
- •Subject enrollment in another study involving a study medication within 30 days of CD
- •Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
研究组 & 干预措施
Phenylephrine bolus
干预措施: Phenylephrine bolus (Drug)
Phenylephrine infusion
干预措施: phenylephrine infusion (Drug)
结局指标
主要结局
Incidence of Nausea and Vomiting
时间窗: 24hrs postoperative
次要结局
- Incidence of Hypotension(intraoperative - postdelivery)
- Neonatal Acidosis(intraoperative)
研究者
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre