Comparison of the Effectiveness of Bolus Doses of Norepinephrine 4 mcg and Phenylephrine 50 mcg in Managing Hypotension After Spinal Anesthesia in Cesarean Section Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure (SBP) After Vasopressor Administration
研究概览
简要总结
This clinical trial was conducted to compare the effectiveness and safety of two medications-norepinephrine and phenylephrine-in treating low blood pressure (hypotension) that often occurs during spinal anesthesia for cesarean section (C-section) deliveries. Spinal anesthesia is commonly used during C-sections but can cause a drop in the mother's blood pressure, which may affect both the mother and the baby.
In this study, 46 pregnant women undergoing elective C-sections were randomly given either norepinephrine (4 mcg) or phenylephrine (50 mcg) when their blood pressure dropped. Researchers monitored their heart rate, blood pressure, and any side effects for 30 minutes after anesthesia.
The results showed that both drugs were effective in raising blood pressure. However, norepinephrine kept the heart rate more stable, while phenylephrine caused a noticeable slowing of the heart rate (bradycardia). Both drugs were safe and well tolerated.
This study suggests that norepinephrine may be a better option for managing low blood pressure during spinal anesthesia in C-sections, especially when maintaining heart rate and cardiac output is important.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Female patients aged 18-40 years
- •Undergoing elective cesarean section
- •Receiving spinal anesthesia
- •Classified as ASA Physical Status II
- •Stable baseline hemodynamics prior to anesthesia
- •Not using inotropic, chronotropic, or vasoactive drugs before surgery
排除标准
- •Emergency cesarean section
- •Fetal distress
- •Preeclampsia or eclampsia
- •Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site)
- •Known allergy to norepinephrine or phenylephrine
- •Hemodynamic instability prior to vasopressor administration
- •Withdrawal from study or refusal to participate
- •Failure to develop post-spinal hypotension
研究组 & 干预措施
Norepinephrine Group
Participants in this group received intravenous bolus doses of norepinephrine 4 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section.
干预措施: Norepinephrine 4mcg (Drug)
Phenylephrine Group
Participants in this group received intravenous bolus doses of phenylephrine 50 mcg (2 mL) diluted in normal saline to treat spinal anesthesia-induced hypotension during cesarean section
干预措施: Phenylephrine 50 mcg (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure (SBP) After Vasopressor Administration
时间窗: Baseline to 2 minutes post-administration (T0-T2)
Change in systolic blood pressure measured before vasopressor administration (T0-T1) and two minutes after administration (T2) in response to intravenous bolus of norepinephrine 4 mcg or phenylephrine 50 mcg during spinal anesthesia-induced hypotension in cesarean section patients.
次要结局
未报告次要终点
研究者
Imam Syahputra
dr
Universitas Sumatera Utara