Comparison of Two Doses of 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
- 124
- 试验地点
- 1
- 主要终点
- systolic blood pressure variation during cesarean delivery
研究概览
简要总结
The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 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, the study participants will be randomly assigned using a computer generated table to 1 of 2 treatment groups prior to cesarean delivery.
Group A will receive an intravenous bolus of 1mcg/Kg of norepinephrine bitartrate to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal anesthesia.
Group B will receive an intravenous bolus of 0.5mcg/kg of norepinephrine bitartrate to maintain systolic blood pressure (SBP) within 80-120% of baseline before the spinal anesthesia.
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 as the mean of three consecutive SBP measurements taken 3 minutes apart. 500 mL of Lactated Ringer 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
- •Elective or semi-urgent CD under spinal anesthesia
- •Age over 18 years
- •Healthy singleton pregnancy beyond 36 weeks' gestation
- •American Society of Anesthesiologists (ASA) physical status classification 2
- •Weight 50 to 100 kg, and height 150 to 180 cm
排除标准
- •Emergency CD red code ( extraction time <15 min)
- •Allergy or hypersensitivity to norepinephrine or sulfite
- •Preexisting or pregnancy-induced hypertension, preeclampsia, eclampsia, the use of cardiac medication or medication for blood pressure control
- •multiple gestation
- •Cardiovascular or cerebrovascular disease
- •Fetal abnormalities
- •Suspicion of abnormal placentation
- •History of diabetes mellitus (excluding gestational diabetes)
- •Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
- •documented history of postoperative nausea and vomiting, previous gastric bypass surgery, history of chronic opioid use (chronic pain syndrome)
- •Patient refusal
研究组 & 干预措施
B
group B: will receive 0.5 mcg/Kg of Norepinephrine intravenously
干预措施: Norepinephrine 0,5mcg/kg (Drug)
结局指标
主要结局
systolic blood pressure variation during cesarean delivery
时间窗: time from immediately after spinal anesthesia until the end of surgery
difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred during the cesarean section
mean blood pressure variation before delivery
时间窗: time from immediately after spinal anesthesia until delivery
difference between the baseline mean blood pressure(MBP0) and the lowest mean blood pressure (MBPmin) registred before delivery and computed as (MBP min -MBP0)/MBP0
systolic blood pressure variation before delivery
时间窗: time from immediately after spinal anesthesia until delivery
difference between the baseline systolic blood pressure (SBP0) and the lowest systolic blood pressure (SBPmin) registred before delivery and computed as (SBP min -SBP0)/SBP0
mean blood pressure variation during cesarean delivery
时间窗: time from immediately after spinal anesthesia until the end of surgery
difference between the baseline mean blood pressure (MBP0) and the lowest systolic blood pressure (MBPmin) registred during the cesarean section
次要结局
- Time to administartion of the first rescue bolus(time from immediately after spinal anesthesia until delivery)
- duration of hypotension(immediately after spinal anesthesia until the end of surgery)
- number of rescue boluses(immediately after spinal anesthesia until the end of surgery)
- Incidence of hypotension(tile from right after spinal anesthesia until delivery)
- Vomiting(time of surgery (right after spinal anesthesia until end of surgery))
- arrhythmia(time of surgery (right after spinal anesthesia until end of surgery))
- Hypertension(right after spinal anesthesia until end of surgery)])
- Norepinephrine consumption(time fro right after spinal anesthesia until the end of surgery)
- Bradycardia(immediately after spinal anesthesia until the end of surgery)
- Nausea(time of surgery (right after spinal anesthesia until end of surgery))
- Apgar score(at time of birth)
- mean pH of the fetal cord blood(time of birth)
研究者
Ben marzouk Sofiene
clinical associate professor
University Tunis El Manar