Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Transient Neurologic Syndrome Incidence
研究概览
简要总结
5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia because it has been blamed responsible for the so-called transitory neurological syndrome (TNS). This entity appears particularly in patients operated on lithotomy and knee arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of 10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery cases. Other local anesthetics are not competitive with general anesthesia in time to be discharged home from the SDS unit. The magnesium ion is well-known for its protective properties on cells with electrical activity. The objective is to confirm that the magnesium ion added as adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this hypothesis could be confirmed, the practical and theoretical consequences would be far-reaching.
The method to achieve our objective would be a double-blinded randomized clinical trial considering two groups of intrathecal lidocaine: with and without added IT magnesium.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Same day surgery patients
- •Operated in lithotomy or arthroscopy position or obese patients
排除标准
- •American Society of Anesthesia 3 or 4 patients
- •Younger than 18 or elder than 80 years-old
- •Active lumbar pain
- •Any short of chronic neurologic disease
- •Any short of myopathy
- •Pregnant women
- •Previous history of allergic or toxic reaction to lidocaine, magnesium or fentanyl
研究组 & 干预措施
Intrathecal magnesium
Intrathecal magnesium sulfate 15% 0,5 mL (75 mg) is added to lidocaine 5% 1 mL (50 mg)as anesthetic adjuvant
干预措施: Magnesium sulfate (Drug)
Intrathecal magnesium
Intrathecal magnesium sulfate 15% 0,5 mL (75 mg) is added to lidocaine 5% 1 mL (50 mg)as anesthetic adjuvant
干预措施: Lidocaine (Drug)
Intrathecal fentanyl
Intrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant
干预措施: Fentanyl (Drug)
Intrathecal fentanyl
Intrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant
干预措施: Lidocaine (Drug)
结局指标
主要结局
Transient Neurologic Syndrome Incidence
时间窗: 7 postoperative days
Transitory neurological syndrome appears particularly in patients operated on lithotomy and knee arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of 10) buttocks-legs pain, self-limited in time, but disturbing enough to be avoided in same-day-surgery cases.
次要结局
未报告次要终点
研究者
Javier Pascual-Ramirez
MD, PhD
Hospital General de Ciudad Real