The Effects of Perioperative Low-dose Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- visual analog scale
研究概览
简要总结
Effective postoperative analgesia after lumbar spine surgery (e.g., laminectomy, vertebroplasty, lumbar stabilization) is associated with faster recovery and shorter hospital stay. Multimodal analgesia aims to reduce opioid consumption and related adverse effects by combining agents with complementary mechanisms of action at peripheral and central levels.
Magnesium is one of the agents used in this approach. Its analgesic effects are attributed to inhibition of neuropathic pain, potentiation of opioid analgesia, and attenuation of opioid tolerance. Mechanistically, magnesium acts as a non-competitive NMDA receptor antagonist and modulates intracellular calcium influx, thereby reducing central glutamate release and limiting hyperalgesia.
However, the clinical efficacy of perioperative magnesium remains controversial. Outcomes may vary depending on timing (intraoperative vs. postoperative), dosing strategies (bolus vs. infusion), and total administered dose. The optimal dosage, administration method, safety profile, and dose-response relationship of magnesium for analgesic purposes are not yet clearly established.
This study aims to evaluate the effectiveness of perioperative low-dose magnesium sulfate (MgSO₄) in this context.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years and older,
- •ASA (American Society of Anesthesiologists) physical status I-II,
- •awaiting to undergo lumbar spinal surgery under general anesthesia.
排除标准
- •the presence of cardiac conduction disorders and/or cardiac comorbidities
- •use of Ca channel blockers,
- •hepatic/renal failure and allergy to Mg.
研究组 & 干预措施
the magnesium treatment group (Group M)
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of MgSO4 (10 mg/kg/h) in 100 mL of normal saline (NS) was initiated in groups M, respectively.
干预措施: Magnesium sulfate (Drug)
the control group (Group C)
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of and an infusion of 100 mL of NS (10 mg/kg/h) was initiated in groups C, respectively.
干预措施: normal saline (Drug)
结局指标
主要结局
visual analog scale
时间窗: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity. It typically consists of a 10-cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10), on which patients mark the point that best represents their perceived pain level.
次要结局
- diastolic blood pressure(It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period)
- heart rate(It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period)
- sistolic blood pressure(It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period)
- Richmond Agitation-Sedation Scale.(It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.)
研究者
Aysel Salkaya
Anesthesiologist
Sisli Hamidiye Etfal Training and Research Hospital