Shivering Prevention During Cesarean Section by Intrathecal Injection of Magnesium Sulfate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Shivering Score
研究概览
简要总结
Shivering is a common post-anesthetic complication occurring in up to 65% of patients undergoing spinal or epidural anesthesia. Shivering may interfere with electrocardiogram, blood pressure and oxygen saturation monitoring. In addition, shivering increases oxygen consumption, carbon dioxide production and metabolic rate by up to 400%. Thus, it may result in problems in patients with low cardiac and pulmonary reserves. Preventing shivering could therefore result in better postoperative outcomes or reduce the incidence of post-surgical complications.
详细描述
Magnesium sulfate (MgSO4) has anti-shivering effects. Moreover, it has potential neuroprotective effects and may enhance neuroprotection against the effects of hypothermia. Intrathecal MgSO4 administration provides effective perioperative analgesia and can prolong the period of anesthesia and sensory blockade without any additional side-effects. However, most of the research on the role of MgSO4 in the prevention of shivering has focused on intravenous infusion of this drug. Few clinical trials have examined the effect of adding intrathecal MgSO4 to anesthetic agents such as bupivacaine to suppress anesthesia-related shivering in patients. Similar to infusion studies, we hypothesized that the addition of intrathecal injection of MgSO4 to bupivacaine would improve perioperative shivering in female patients undergoing elective caesarean section. Few previous studies evaluated neuroaxial anti-shivering effects of intrathecal magnesium and none evaluated the anti-shivering effect of intrathecal MgSO4. Therefore, we elected to use the lowest dosage (25 mg MgSO4) that was formerly utilized for investigation of analgesic effects.
Magnesium sulphate is an intracellular cation with various physiologic functions such as enzyme activation, nerve signal conduction, protein synthesis and vasomotor tonicity regulation. Magnesium sulphate has been used in various clinical situations including preeclampsia, tocolysis, arrhythmias, myocardial ischemia, bronchial asthma and postoperative shivering.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 35years.
- •Undergo elective cesarean section under spinal anesthesia.
- •ASA physical status I-II.
- •Singleton pregnancy.
- •At least 38 weeks gestation.
排除标准
- •Women with history of cardiac, liver or kidney diseases.
- •Women with allergy to amide local anesthetics or medication included in the study.
- •Women with any neurological problem.
- •Any contraindication of regional anesthesia.
- •Failed or insatisfactory spinal block.
- •Preoperative temperature more than 38⁰ C.
研究组 & 干预措施
Group M
2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally
干预措施: MgSo4 (Drug)
Group P
2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally
干预措施: Placebo (Drug)
结局指标
主要结局
Shivering Score
时间窗: 2 hours
shivering will be recorded in the recovery room for 2 hours
次要结局
- Visual Analogue Pain Score(2 hours)
- Complications(2 hours)
研究者
MOHAMED F. MOSTAFA
Lecturer of Anesthesia and Intensive Care
Assiut University