Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Sensitive block duration
研究概览
简要总结
This study evaluates the addition of continuous infusion of lidocaine or continuous infusion of magnesium sufate in the duration of spinal anesthesia.
详细描述
Both lidocaine and magnesium sulfate have been shown to prolong spinal anesthesia.
The number of studies using magnesium sulfate to improve spinal anesthesia is greater than the number of studies using lidocaine, and methodology varies significantly between studies.
Adverse effects of lidocaine are different from magnesium sulfate's. Lidocaine has a wider therapeutic interval with fewer side effects, including: Drowsiness, Feeling Anxious, Feeling Cold, Nervous, Numbness And Tingling, Signs And Symptoms At Injection Site, Twitching.
Magnesium sulfate's side effects include: heart disturbances, breathing difficulties, poor reflexes, confusion, weakness, flushing (warmth, redness, or tingly feeling), sweating, lowered blood pressure, feeling like you might pass out, anxiety, cold feeling, extreme drowsiness, muscle tightness or contraction, or headache.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will receive spinal anesthesia for TURP por Histerectomy
排除标准
- •Protocol violation;
- •Severe adverse events;
- •Change to general anesthesia or addition of epidural anesthesia;
- •Complete or partial spinal block failure;
- •Mental status alteration (agitation, confusion, loss of conciousness).
研究组 & 干预措施
Magnesium Sulfate
Continuous intravenous infusion of 15mg/kg/h of magnesium sulfate, starting just after spinal anesthesia infusion until the end of surgery
干预措施: Magnesium Sulfate (Drug)
Lidocaine
Continuous intravenous infusion of 1.5mg/kg/h of lidocaine, starting just after spinal anesthesia infusion until the end of surgery
干预措施: Lidocaine (Drug)
结局指标
主要结局
Sensitive block duration
时间窗: 9 hours
Thermal and pinprick level lowering to S2
次要结局
- Motor block duration(9 hours)
- Two levels regression(9 hours)
- Pain at postanesthesia care unit(1-3 hours)
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of Anesthesia
Brasilia University Hospital