The Effect of Different Doses of Intrathecal Magnesium Sulfate on Shivering After Spinal Anesthesia in Cesarean Sections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Level of shivering
研究概览
简要总结
Shivering after spinal anesthesia is a common complication. Mangesium sulfate, which can be used intrathecally, is effective in preventing tremor. But what is the ideal dose?
详细描述
Perioperative shivering during cesarean section (CS) under neuraxial anesthesia (NA) is clinically common, but its treatment is often neglected.
When the literature is scanned, perioperative tremors are seen in 55%-60% of patients undergoing neuraxial anesthesia. However, the mechanism of the tremor has not been fully elucidated. Possible factors that can cause tremor can be listed as follows:
- Loss of thermoregulatory vasoconstriction below the block level,
- The displacement of body temperature from the central to the periphery due to vasodilation,
- Increased sweating threshold and decreased peripheral vasoconstriction Perioperative shivering is a complication that needs to be treated because it causes dangerous consequences in patients with low cardiopulmonary reserve due to increased oxygen consumption and impairs patient and surgeon comfort.
Magnesium sulfate is one of the most effective adjuvant drugs with the least side-effect profile in the treatment of tremor after noxial block.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Who were scheduled for elective C/S under SA,
- •18-40 years of age
- •ASA physical status I-II.
排除标准
- •Any contraindications to SA,
- •preoperative body temperature >38 C,
- •allergy to any drug used in the study,
- •pre-eclampsia, and eclampsia,
- •neuropathy,
- •respiratory distress,
- •coagulopathy, and
- •any possible drugs that can change body temperature,
- •ASA physical status > II.
研究组 & 干预措施
Group C
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 1 mL normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)
干预措施: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) (Drug)
Group M25
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 25mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
干预措施: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) (Drug)
Group M50
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 50 mg/mL MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 50mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey).
干预措施: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) (Drug)
Group M100
Patients receiving intrathecal 10 mg hyperbaric bupivacaine (Marcaine® Spinal Heavy %0.5, Sanofi, Kırklareli, Turkey) + 100 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey). MgSO4 diluted to 100mg/mL with normal saline (Polifleks %0.9 İzotonik Sodyum Klorür, Polifarma, Ankara, Turkey)
干预措施: 25 mg MgSO4 (Magnezyum Sulfat %15, Biofarma, Istanbul, Turkey) (Drug)
结局指标
主要结局
Level of shivering
时间窗: 3 mounths
Intraoperative and postoperative shivering will be evaluated with the shivering test established by Crossley and Mahajan. flicker tracking; The parameters looked at in this test approved by Crossley and Mahajan are: 0 = no flicker, 1. = Piloerection or peripheral vasoconstriction, but no visible shivering, 2. = Muscle activity in only 1 muscle group, 3. = more muscle activity than 1 muscle group but not generalized 4. = Full body shivering
次要结局
未报告次要终点
研究者
Nureddin YUZKAT
Assoc. proffesor
Yuzuncu Yıl University