Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia
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
- Intraoperative vomiting
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:
Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.
Which drug is the best at reducing intraoperative pain.
Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.
A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.
Data collected from the three groups will be analyzed using SPSS software.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age above 20 but less than 35 years old
- •Given informed consent
- •No contraindication to spinal anesthesia
- •ASA I or II
排除标准
- •Age less than 20 or more than 35 years old
- •Non-consenting
- •Contraindication to spinal anesthesia
- •ASA III or IV
研究组 & 干预措施
Ondansetron
Patients given Ondansetron (8mg)
干预措施: Ondansetron 8mg (Drug)
Dexamethasone
Patients given Dexamethasone (8mg)
干预措施: Dexamethasone 8mg (Drug)
Placebo
干预措施: Normal saline (Drug)
结局指标
主要结局
Intraoperative vomiting
时间窗: 1 hour
Number of episodes of vomiting throughout the procedure
Intraoperative nausea
时间窗: 20 minutes after initiation of procedure
Measured by an 11-point numeric rating scale
次要结局
- Intraoperative pain(20 minutes after the initiation of procedure)
研究者
Muhammad Mubariz
House Officer
Akhtar Saeed Medical and Dental College