Effect of addition of Magnesium sulfate as an adjuvant to intrathecal hyperbaric Bupivacaine -fentanyl in patients with preeclampsia without severe features undergoing caesarean section - A Prospective Randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- No. of Requirement of rescue analgesia
研究概览
简要总结
The aim of study is to evaluate the effect of adding magnesium sulphate intrathecally to bupivacaine - fentanyl combination in patients with preeclampsia without severe features undergoing caesarean section.
90 pregnant women with preeclampsia without severe features will be randomly decided into two groups , In each group there will be 45 patients who are posted for elective caesarean section .
In one group Group Bf - Bupivacaine heavy (0.5% ) 2 ml + fentanyl 25mcg ( 0.5 ml ) + Preservative free saline 0.1 ml = total 2,6 cc drug volume given
in second group Group BFM - Bupivacaine heavy (0.5%)2ml + fentanyl 25 mcg (0.5 ml ) +Preservative free 50 % magnesium sulphate 50 mg 0.1 ml = total 2.6 cc drug volume given
Requirement of rescue analgesia over 24 hours as primary outcome
As a secondary outcome ,Duration of post operative analgesia till 24 hours , hemodynamic parameters , spinal block characteristics ,any complications will be assessed .
The proposed advantage of the study will be that the addition of intrathecal magnesium sulphate to combination of bupivacaine -fentanyl in patients with preeclampsia without severe features undergoing caesarean section will lead to prolong duration of postoperative analgesia as well as reduced requirement of rescue analgesia with minimal side effects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant female with preeclampsia without severe features (systolic bp 140-160 mmhm and diastolic bp 90-110 mmhmg)
- •pregnant women with mild preeclampsia without severe features posted for elective caesarean section to be operated under spinal anaesthesia 3.pregnant women with mild preeclampsia without severe features having height ranging between 150 to 170 cm and weight ranging between 50 to 90 kg.
排除标准
- •Patient refusal
- •Patient with contraindication to spinal anaesthesia like allergy to local anaesthetics drug ,local infection ,raised intracranial pressure, spinal deformity , coagulopathy 3.Pregnant women with coexisting systemic disorders 4.Pregnant women taking magnesium therapy 5.Eclampsia
- •Psychiatric illness
- •active labour, twin pregnancy ,complicated pregnancy.
结局指标
主要结局
No. of Requirement of rescue analgesia
时间窗: Till 24 hours
次要结局
- 1.Duration of post operative analgesia(2.Changes in hemodynamic parameters perioperartively)
研究者
Dr Nrutvi Gajera
Goverment Medical college Baroda