A Comparative Study Between Intrathecal Magnesium Sulphate Versus Midazolam Along With Epidural 0.75% Ropivacaine in Combined Spinal Epidural Technique for Preeclampsia Parturients Undergiong Elective Caesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Duration of Postoperative Analgesia
研究概览
简要总结
This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine via epidural route.
详细描述
Magnesium sulphate and Midazolam have been used in clinical trials as adjuvants to local anaesthetics via intrathecal and epidural routes and are effective in augmenting the quality of block and prolonging post-operative analgesia.
Noxious stimulation leads to the release of glutamate and aspartate neuratransmitters which bind to various sub-classes of excitatory aminoacid, including the NMDA receptor. Intrathecal magnesium potentiates neuraxial anaesthesia by blocking NMDA receptors with out causing significant side effects as reported in various studies.
Intrathecal Midazolam produces antinociception at spinal cord-level through benzodiazepine GABA-A receptor complex which are present abundantly in the lamina 2 of spinal cord. Midazolam also releases endogenous opioid acting at spinal delta receptors and also enhances adenosine release which also augments analgesia.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 28 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •50 pregnant women
- •ASA-I and II parturients
- •Weight 50-80 kgs
- •Pre-eclampsia
排除标准
- •Thrombocytopenia
- •HELLP syndrome
- •Parturients on magnesium therapy
- •Foetal distress
- •Parturients on benzodiazepine therapy
- •Patient refusal
- •Contraindications to regional anaesthesia
研究组 & 干预措施
GROUP A(MAGNESIUM GROUP)
MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
干预措施: intrathecal magnesium sulphate, (Drug)
GROUP B(MIDAZOLAM GROUP)
MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.
干预措施: Intrathecal midazolam (Drug)
结局指标
主要结局
Duration of Postoperative Analgesia
时间窗: first 12 hours after completion of surgery.
pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.
次要结局
- Onset of Sensory Blockade(every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..)
- Duration of Sensory Blockade(every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..)
- Onset of Motor Blockade(every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.)
- Duration of Motor Blockade(every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.)
- Perioperative Side Effects(through out the intraoperative period and first 12 postoperative hours.)
研究者
Dr. Paleti Sophia
Principle investigator
Rangaraya Medical College