Role of Ondansetron and Hydrocortisone combination in prevention of PDPH after spinal anaesthesia for caesarean section
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the incidence of Post dural puncture headache at 24 hrs, 48hrs, 72 hrs and follow up upto a week in parturient who have received the prophylactic combination of ondansetron and Hydrocortisone versus the control group who have not received any of the above prophylactic medications
研究概览
简要总结
Spinal anaesthesia is one of the most commonly used anaesthetic technique for caesarean delivery, but it always carries a risk of PDPH which can occur despite maximum care to prevent it. No studies have been done regarding prophylactic use of combination of Ondansetron and hydrocortisone in prevention of PDPH, even though individually each drug has been studied for treatment/prevention of PDPH.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Parturient posted for elective caesarean sections with American Society of anaesthesiologists physical status 2, with Body mass index of less tha 35 kg/m2.
排除标准
- •Parturient unwilling to participate in study, with history of chronic steroid use, history of migraine, preeclampsia, eclampsia, gestational diabetes mellitus.
结局指标
主要结局
To compare the incidence of Post dural puncture headache at 24 hrs, 48hrs, 72 hrs and follow up upto a week in parturient who have received the prophylactic combination of ondansetron and Hydrocortisone versus the control group who have not received any of the above prophylactic medications
时间窗: To compare the incidence of Post dural puncture headache at 24 hrs, 48hrs, 72 hrs and follow up upto a week in parturient who have received the prophylactic combination of ondansetron and Hydrocortisone versus the control group who have not received any of the above prophylactic medications
次要结局
- To compare incidence of Postoperative Nausea and vomiting between the two groups(occurrence of nausea and vomiting till 3 days postop)
研究者
Dr MANOJ DASS L
Kasturba Medical College Hospital, Manipal