跳至主要内容
临床试验/CTRI/2025/03/082160
CTRI/2025/03/082160
尚未招募
4 期

Comparison of efficacy and safety of preoperative, intraoperative and postoperative Magnesium sulfate (MgSO4) in reducing post operative pain in patient undergoing spinal anesthesia- A prospective, randomized, study.

Dr Shubha Singhal1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年4月12日最近更新:

概览

阶段
4 期
状态
尚未招募
发起方
Dr Shubha Singhal
入组人数
102
试验地点
1
主要终点
To evaluate the opioid consumption in post operative period (first 24 hours) in preoperative, intraoperative and post operative MgSO4 administration

概览

简要总结

Postoperative pain is a significant factor that impacts the surgical outcome and course of treatment. The major goal of postoperative pain management is to reduce the dose of medications and consequently the incidence of side effects, while ensuring sufficient pain relief. Postoperative pain relief leads to earlier mobilization, shortened hospital staying, reduced hospital costs, and increased patient satisfaction .

Opioids are the most frequently used analgesics for postoperative pain. However, they have their own limitations and adverse effects including constipation, pruritis, altered mental state and respiratory depression. Hence, there is need of certain adjuvant analgesics which reduce the requirement of opioids without compromising the post operative pain relief and recovery

Magnesium (Mg) is a positively charged divalent cation which has minimal side effects and has long been utilized in medical practice as an anticonvulsant or antiarrhythmic drug .  Being an NMDA receptor antagonist, magnesium has the potential to be employed as an adjuvant analgesic. Furthermore, it also disrupts the entry of calcium into the cell and produces central analgesic action.  At the peripheral level, it inhibits the release of catecholamine from the sympathetic neurons, resulting in a reduction of peripheral nociception and the stress reaction after surgery.

There are studies which evaluate the role of magnesium as an adjuvant analgesic. Most of them were carried out in patients who were undergoing surgery under general anaesthesia. Relatively few studies have been conducted on the effects of magnesium sulphate administration during spinal anaesthesia [1, 2,7]. Furthermore, most of them evaluated the role of perioperative IV magnesium in reducing post operative pain. To the best of our knowledge, none of the studies evaluate the efficacy of IV MgSO4 in intraoperative and post operative period under spinal anaesthesia. Peng at el also confirmed in his metanalysis that there is need of future research that evaluates the effect of time of delivery of IV magnesium sulphate on analgesia  Hence, the current study is planned to evaluate and compare the efficacy and safety of preoperative, intraoperative and post operative IV magnesium sulphate under spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease) 3) Patient coming for lower limb surgery requiring spinal anesthesia 4) Patients stay for at least 24 hours postoperatively.

排除标准

  • Patients undergoing surgery other than lower limb surgery due to trauma 2) Patient requiring surgery under general anaesthesia 3) Known case of neuromuscular disease or heart block or respiratory diseases 4) Renal dysfunction 5) Patient on calcium channel blockers 6) Allergic to MgSO4 7) Pregnant female 8) Lactating mother 9) Any other contraindication for spinal anaesthesia.

结局指标

主要结局

To evaluate the opioid consumption in post operative period (first 24 hours) in preoperative, intraoperative and post operative MgSO4 administration

时间窗: At 0, 2, 6, 12 hour

次要结局

  • To assess the safety and tolerability, the number of adverse effects(At 0, 2, 6, 12 hour)

研究者

发起方
Dr Shubha Singhal
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shubha Singhal

AIIMS, Rajkot

研究点 (1)

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