Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section: A Comparative Study
Spinal anesthesia is widely used for cesarean deliveries, but shivering is a frequent complication that occurs in 40% to 60% of patients. Post-spinal shivering can cause maternal discomfort, increase oxygen consumption and metabolic demands, and interfere with clinical monitoring. Both paracetamol and magnesium sulfate have thermoregulatory properties that may prevent or reduce shivering.
The purpose of this clinical trial is to compare the efficacy and safety of intravenous paracetamol versus intravenous magnesium sulfate in preventing and reducing shivering following spinal anesthesia in women undergoing elective cesarean section.
A total of 90 pregnant women scheduled for elective cesarean delivery will be randomly assigned to one of two groups:
- Group P (Paracetamol Group): Participants receive intravenous paracetamol (15 mg/kg) infused over 15 minutes immediately following the subarachnoid block.
- Group M (Magnesium Sulfate Group): Participants receive intravenous magnesium sulfate (30 mg/kg) administered immediately following the subarachnoid block.
The primary outcome evaluated is the severity of post-spinal shivering assessed by shivering scores. Secondary outcomes include hemodynamic parameters (heart rate, blood pressure, oxygen saturation), postoperative pain, complications such as nausea and vomiting, and maternal satisfaction.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status class I or II
- Pregnant women aged 20 to 40 years
- Term gestation (>= 37 weeks) with an uncomplicated pregnancy
- Scheduled for elective cesarean delivery under planned spinal anesthesia
- Patient agreement and signed written informed consent
Exclusion Criteria:
- Patient refusal
- Morbid obesity (BMI > 35 kg/m²)
- Contraindications to spinal anesthesia
- Significant organ dysfunction (e.g., cardiac, respiratory, renal, or hepatic disorders)
- Known hypersensitivity or allergy to paracetamol or magnesium sulfate
- Cardiovascular or neuromuscular disorders in which magnesium administration is contraindicated
- Emergency cesarean section
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Group P: Paracetamol Group
Participants receive intravenous paracetamol at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 15 mg/kg infused over 15 minutes immediately after the completion of the subarachnoid block. |
|
有源比较器：Group M: Magnesium Sulfate Group
Participants receive intravenous magnesium sulfate at a dose of 30 mg/kg administered immediately after the completion of the subarachnoid block. |
Administered intravenously at a dose of 30 mg/kg immediately after the completion of the subarachnoid block. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-Spinal Shivering Score
大体时间：Up to 2 hours postoperatively
|
Post-spinal shivering severity is assessed using a 5-point shivering scale where Grade 0 indicates no shivering; Grade 1 indicates piloerection or peripheral vasoconstriction without visible shivering; Grade 2 indicates muscular activity in only one muscle group; Grade 3 indicates muscular activity in more than one muscle group, but not generalized; and Grade 4 indicates generalized, whole-body shivering. Total scores range from 0 to 4, with higher scores representing greater shivering severity |
Up to 2 hours postoperatively
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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