Ephedrine vs. Nor-epinephrine Infusion 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 norepinephrine is more effective as a continuous intravenous (IV) infusion compared to continuous IV ephedrine 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 morphine. 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: A continuous Ephedrine infusion 10 mcg/kg/min to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.1 mcg/kg/min 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
- •The American Society of Anesthesiologists (ASA) Physical Status classification 1 and 2
- •Pregnant women with singleton pregnancy
- •Gestational age greater than 36 weeks
- •Cesarean delivery under spinal anesthesia
排除标准
- •Use of cardiac medication or medication for blood pressure control
- •Cardiovascular disease
- •Multiple gestation
- •Gestation diabetes requiring insulin
- •Refusal to be in study
- •History of chronic opioid use (chronic pain syndrome)
- •Emergent caesarean delivery for maternal and/or fetal distress
- •Preeclampsia
- •Eclampsia
- •Progressive neurologic disease
- •Infection at insertion site
- •Allergy to local anesthetics, narcotics or other study medications
研究组 & 干预措施
Ephedrine
A continuous Ephedrine infusion at 10 mcg/kg/min
干预措施: Ephedrine (Drug)
Norepinephrine
A continuous Norepinephrine infusion at 0.1 mcg/kg/min
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 untill 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 untill end of surgery))
- Vomiting(AT TIME OF SURGERY (right after spinal anesthesia untill 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 untill end of surgery))
- Nausea(AT TIME OF SURGERY (right after spinal anesthesia untill end of surgery))
研究者
Ben marzouk Sofiene
MD, assistant professor
University Tunis El Manar