NCT05202574Unknown2 期
Comparing the Effects of Ondansetron Versus Dexamethasone on the Incidence of Post-dural Puncture Headache (PDPH) , Nausea and Vomiting After Spinal Anaesthesia of Parturients Undergoing Caesarean Section
Minia University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- incidence of post-dural puncture hedache
研究概览
简要总结
Comparing dexamethasone and ondanestrone injection in ncidence of postdural puncture headache and post-partum nausea and vomiting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A total of one hundred and fifty parturients in child bearing period (20-40 years), with BMI of 23-27, and ASA physical status II, who were candidate for elective caesarean section, were enrolled in this prospective randomized study.
- •Exclusion criteria
排除标准
- •1 - Lady refusal to participate.
- •All pregnant women candidate for emergency caesarean section elligible for general anaesthesia (GA).
- •3.presence of any contraindications of dexamethasone (as DM and uncontrolled infection ) or any contraindication of ondansetron (as prolonged QT interval
- •Presence of cardiac, respiratory, hepatic, renal and mental diseases.
- •Coagulopathy, or any contraindication to spinal anaesthesia.
- •Presence of complicated pregnancies (such as pregnancy induced hypertension, placenta previa or eclmpsia).
研究组 & 干预措施
control group
Placebo Comparator
干预措施: Intravenous drug (Drug)
dexamethasone
Active Comparator
干预措施: Intravenous drug (Drug)
ondanestrone
Active Comparator
干预措施: Intravenous drug (Drug)
结局指标
主要结局
incidence of post-dural puncture hedache
时间窗: 24 hours post-partum
次要结局
- incidence of post-partum nausea and vomiting(24 hours post-partum)
研究者
Mina Maher
Lecturer of anesthesia and ICU
Minia University
研究点 (1)
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