Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia for Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maternal Blood Pressure
研究概览
简要总结
The purpose of the study is to determine if an intravenous bolus of phenylephrine is more effective compared to an intravenous bolus of norepinephrine associated with crystalloid loading for maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Prevention of low blood pressure has been shown to decrease nausea and vomiting during and after cesarean delivery under spinal anesthesia. For elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 120 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
详细描述
This study will be a prospective, randomized, active treatment controlled trial.
After written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will consist of: An intravenous bolus of 0,2 mcg/Kg of norepinephrine to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Group B will consist of: An intravenous bolus of 100mcg of phenylephrine to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Patients will be admitted to holding area. Baseline arterial blood pressure and heart rate will be measured in supine position, with left uterine displacement. Baseline blood pressure will be calculated by taking the mean of three consecutive SBP measurements taken 5 minutes apart. 500 mL of Lactated Ringers solution will be administered immediately after induction of spinal anesthesia at the outflow rate of 100ml per hour.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •of Anesthesiologists (ASA) Physical Status classification 1 and 2
- •Pregnant women with singleton pregnancy
排除标准
- 未提供
研究组 & 干预措施
Phenylephrine
A bolus of 100 mcg
干预措施: Phenylephrine (Drug)
Norepinephrine
A bolus of 0,2 mcg/kg
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Maternal Blood Pressure
时间窗: At time of surgery (right after spinal anesthesia until end of surgery)
Measurement of systolic, diastolic and mean, non-invasive blood pressure during cesarean section with an infusion of either Ephedrine or Norepinephrine
次要结局
- Hemodynamic Parameters - arrhythmia(At time of surgery (right after spinal anesthesia until end of surgery))
- mean pH of the fetal cord blood in each group(At time of birth)
- Hemodynamic Parameters - heart rate(At time of surgery (right after spinal anesthesia until end of surgery)
- Vomiting(At time of surgery (right after spinal anesthesia until end of surgery))
- Nausea(At time of surgery (right after spinal anesthesia until end of surgery))
研究者
Ben marzouk Sofiene
MD, assistant professor
University Tunis El Manar