Contribution of Ondansetron to Preventing Post-Dural Puncture Headaches Following Spinal Anesthesia for Cesarean Sections : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
研究概览
简要总结
A prospective, bicentric, randomized, double-blind controlled study including parturients scheduled for elective caesarean delivery under spinal anaesthesia and randomized and assigned to one of the two groups:
Group O ondansetron : receiving Intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia Group C control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
详细描述
Spinal anesthesia is the most common anesthetic technique used for Caesarean sections. However, it is not denied from complications.
Post-dural puncture headache is a major complication of spinal anesthesia, with an incidence ranging from 1.5% to 36%.
OBJECTIVE :
To evaluate the efficacy of ondansetron in preventing post-dural puncture headache after spinal anaesthesia for caesarean section.
the investigators conducted a prospective, bicentric, randomized, double-blind controlled study over a period of 07 months from November 2023 to june 2024.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-45 years
- •Between 37 and 41 weeks of gestation
- •scheduled for elective caesarean delivery under spinal anaesthesia
- •To be delivered by unscheduled caesarean section whose indication does not involve a vital maternal or fetal emergency, according to the Lucas' classification
排除标准
- •All patients who required :
- •more than two attempts for spinal anaesthesia
- •conversion to general anesthesia following failure of spinal anesthesia (defined as a sensory block level <T6) or an intraoperative complication (such as hemorrhage or anaphylactic shock).
- •As well as patients who have subsequently withdrawn their consent for participating to our study.
研究组 & 干预措施
Group O
Group ondansetron : parturients receiving intravenous (IV) ondansetron 0.10 mg/ kg diluted in 5 ml normal saline, 5 min before spinal anesthesia
干预措施: Intravenous ondansetron (Drug)
Group C
Group control : receiving IV normal saline 5 ml (control group) 5 min before spinal anesthesia
干预措施: Intravenous normal saline (Drug)
结局指标
主要结局
Incidence of post-dural punction headache (PDPH) during the first seven postoperative days.
时间窗: 7 days
the occurrence of positional headaches at any time postoperatively
次要结局
- day of PDPH's occurence(7 days)
- day of PDPH's resolution(7 days)
- Mean arterial pressure in mmgh(3 days)
- Need for analgesic treatment due to headaches(7 days)
- Occurrence of post-operative nausea and/or vomiting(7 days)
- heart rate(3 days)
- Headache severity(7 days)
研究者
Mhamed Sami Mebazaa
Professor head of anesthesiology and ICU department
Mongi Slim Hospital