Comparative analysis of intrathecal and intravenous infusion of Magnesium Sulphate as adjuvant to spinal anesthesia versus spinal anesthesia with hyperbaric 0.5 percent Bupivacaine in lower abdominal elective surgeries:A prospective randomized double blinded clinical study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Onset and duration of sensory and motor blockade following spinal anaesthesia
研究概览
简要总结
Spinal anaesthesia is the most common technique for lower abdominal surgeries as it provides rapid onset and avoids complications of general anaesthesia. However, when used with bupivacaine alone, its effect is often short-lived, requiring additional analgesics. Magnesium sulphate, through NMDA receptor antagonism and calcium channel regulation, has been shown to enhance analgesia and prolong the duration of spinal block.This prospective randomized double-blind study will compare three groups: spinal anaesthesia with bupivacaine alone, spinal anaesthesia with intravenous magnesium sulphate, and spinal anaesthesia with intrathecal magnesium sulphate. The study will evaluate onset and duration of sensory and motor block, quality of postoperative analgesia, sedation, hemodynamic stability, need for rescue analgesia, and adverse effects. Results may guide safer and more effective use of magnesium sulphate as an adjuvant to spinal anaesthesia in lower abdominal elective surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18- 50 years 2) Study include both male and female 3) All lower limb abdominal surgeries under Spinal Anesthesia 4) Signed informed consent given by legally authorised representative 5) ASA Grade I and II.
排除标准
- •Patient refusal for consent 2) Allergy to the drug 3) Patients with hypertension 4) Recent history of use of other sedatives and anxiolytics 5) Patients with history of muscle weakness and respiratory depression 6) History of spine surgeries in past, history associated with spina bifida, meningocele and meningomyelocele.
结局指标
主要结局
Onset and duration of sensory and motor blockade following spinal anaesthesia
时间窗: Assessed intraoperatively at 2 mins intervals until complete block and postoperatively until regression of sensory blockade (up to 6 hours)
次要结局
- Hemodynamic parameters(heart rate,systolic , diastolic,mean arterial pressure, oxygen saturation)(Measured at baseline, every 5 minutes intraoperatively for the first 30 minutes, then every 15 minutes until the end of surgery, & postoperatively at 30 min, 1 hr, 2 hr, 4 hr, & 6 hr.)
- Duration of postoperative analgesia (time from intrathecal injection to first rescue analgesic request)(Assessed postoperatively until 24 hours.)
- Adverse effects(hypotension, bradycardia, nausea, vomiting, shivering, pruritus, respiratory depression, neurological deficits)(Monitored intraoperatively & postoperatively for 24 hours.)
- Sedation(assessed using Ramsay sedation score)(Intraoperatively every 15 minutes & postoperatively at 30 min, 1 hr, 2 hr, & 4 hr.)
研究者
Dr Kowsalya P
AIIMS,Raipur