Phenylephrine vs. Norepinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Number of Rescue Boluses to Maintain SBP
研究概览
简要总结
The purpose of the study is to determine if a medication called phenylephrine, which helps to control blood pressure, is more effective as a continuous intravenous (IV) infusion compared to continuous IV norepinephrine in maintaining blood pressure during a spinal anesthetic for a cesarean delivery. Good blood pressure control 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 (provides long term pain control after cesarean delivery). This study plans to enroll 80 pregnant research subjects 18 years and above. 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, experimental, observational, randomized open label, 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 phenylephrine infusion 0.1 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% of baseline before the spinal.
Group B will consist of: A continuous norepinephrine infusion 0.05 mcg/kg/min to maintain systolic blood pressure (SBP) within 100-120% 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. IV will be placed. Intravenous ondansetron 4 mg and up to 500 mL of Lactated Ringers solution administered prior to induction of spinal anesthesia.
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
- None
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
- •History of postoperative nausea and vomiting
- •Refusal to be in study
- •Gastric bypass surgery
- •History of chronic opioid use (chronic pain syndrome)
- •Emergent caesarean delivery for maternal and/or fetal distress
- •Eclampsia
- •Progressive neurologic disease
- •Infection at insertion site
- •Allergy to local anesthetics, narcotics or other study medications.
研究组 & 干预措施
Phenylephrine
A continuous phenylephrine infusion at 0.1 mcg/kg/min
干预措施: Phenylephrine (Drug)
Norepinephrine
A continuous norepinephrine infusion at 0.05 mcg/kg/min
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Number of Rescue Boluses to Maintain SBP
时间窗: At time of surgery, up to 2 hours
Number of rescue boluses to maintain the SBP within 100-120% of baseline
Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP
时间窗: At time of surgery, up to 2 hours
Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP
时间窗: At time of surgery, up to 2 hours
次要结局
- Percentage of Participants Experiencing Both Nausea and Emesis(At time of surgery, up to 2 hours)
研究者
Manuel C. Vallejo MD , DMD
Chair; Professor
West Virginia University