Efficacy of two different doses of magnesium sulphate as adjuvant to 0.5percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries- A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Time of requirement of first dose of rescue analgesia(min)
研究概览
简要总结
Magnesium sulphate acts as a N-methyl-D-aspartate (NMDA) receptor antagonist, modulating central sensitization and enhancing the duration and quality of spinal anaesthesia.
Although magnesium has no direct antinociceptive effects, it inhibits calcium ions from entering cells by blocking NMDA receptors resulting in analgesic effect.
Studies had demonstrated that adding 50mg or 100mg of magnesium sulphate to bupivacaine prolongs the onset and duration of sensory and motor blocks, reduces postoperative analgesic consumption and maintains hemodynamic stability without significant adverse effects.
We expect an increase in the duration of postoperative analgesia without any side effects on increasing the dose of magnesium sulphate as an adjuvant in spinal anaesthesia.
Primary Objective: To compare the efficacy of 100mg and 150mg magnesium sulphate as adjuvant to 0.5 percent hyperbaric bupivacaine in spinal anaesthesia for lower limb surgeries.
Secondary Objective: To ensure patient safety and observe for adverse effects if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status 1 or 2 2)Undergoing elective lower limb surgery under spinal anaesthesia 3)Height 140 to 180cms 4)Weight 40 to 80kgs.
排除标准
- •Known allergy to study drugs 2)Contraindications to spinal anaesthesia 3)Significant cardiovascular/renal/hepatic/neuromuscular disorders 4)Psychological disorder.
结局指标
主要结局
Time of requirement of first dose of rescue analgesia(min)
时间窗: upto 12 hrs
次要结局
- Time of onset of sensory block(min)
- Time of onset of motor block(min)
- Duration of sensory block(min)
- Duration of motor block(min)
- Hemodynamic changes- HR, SBP, DBP, SpO2 every 5 minutes for first 30 minutes and then every 15 minutes till the end of surgery
- Post operative VAS score at 1,2,4,6,12 hours(1,2,4,6,12hours)
- Incidence of side effects such as post operative nausea and vomiting(PONV), shivering upto 24hours
研究者
Dr P Bhavya Malika
Kalinga Institute of Medical Sciences