Adding Magnesium Sulphate to Epidural Levobupivacaine in Elective Caesarian Section for Patients With Preeclampsia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain-free period
研究概览
简要总结
This study aims at evaluating the effect of adding magnesium sulphate epidurally as an adjunct to levobupivacaine on the quality of anesthesia and perioperative pain relief in patients with preeclampsia undergoing elective caesarian section (CS).
详细描述
Pregnant women with preeclampsia undergoing elective CS in will be included in the study. All patients participating in the study will be randomly divided into two groups; magnesium sulphate group (study group) and placebo group (control group). Patients in the study group will receive epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml magnesium sulphate 10% (500 mg) while patients in the control group will received epidural 20 ml levobupivacaine hydrochloride 0.5% plus 5 ml saline 0.9%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with preeclampsia undergoing elective CS.
排除标准
- •Age < 20 or > 35 years.
- •Height < 150 or > 180 cm.
- •Body mass index (BMI) > 35 kg/m
- •Active labor.
- •Multifetal pregnancy.
- •Fetal distress.
- •Medical conditions complicating pregnancy.
- •HELLP syndrome.
- •Thrombocytopenia.
- •Hepatic or renal impairment.
- •Pulmonary edema or cyanosis.
- •Placenta previa.
- •Vaginal bleeding or placental abruption.
- •Contraindication for central neuraxial block.
- •History of adverse reaction to any study medication.
- •History of analgesic use.
- •Magnesium therapy.
- •Chronic pain syndrome.
- •Presence of communication difficulties preventing reliable assessment.
- •Refusal to undergo regional anesthesia.
研究组 & 干预措施
Magnesium sulphate group
Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate
干预措施: Levobupivacaine hydrochloride (Drug)
Magnesium sulphate group
Patients will receive epidural levobupivacaine hydrochloride + magnesium sulphate
干预措施: Magnesium sulphate (Drug)
Placebo group
Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%
干预措施: Levobupivacaine hydrochloride (Drug)
Placebo group
Patients will receive epidural levobupivacaine hydrochloride + saline 0.9%
干预措施: Saline 0.9% (Drug)
结局指标
主要结局
Pain-free period
时间窗: 24 hours after the epidural anesthesia
The time from reaching sensory block to onset of pain
次要结局
未报告次要终点
研究者
Mohamed Sayed Abdelhafez
Dr
Mansoura University