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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of Postdural Puncture Headache (PDPH)
研究概览
简要总结
This prospective, randomized, double-blind, placebo-controlled study was conducted at the Obstetrics and Gynecology Department of El-Minia University Hospital from October 2018 to October 2019. It enrolled 150 parturients aged 18-45 years undergoing elective cesarean section under spinal anesthesia. Participants were randomly assigned to one of three groups to receive either 8 mg IV ondansetron, 8 mg IV dexamethasone, or 5 mL of IV normal saline 5 minutes before spinal anesthesia. The primary objective was to evaluate the effectiveness of prophylactic ondansetron and dexamethasone in reducing the incidence of postdural puncture headache (PDPH). Secondary outcomes included severity and duration of PDPH, incidence and severity of nausea and vomiting, hemodynamic parameters, and neonatal Apgar scores. Ethical approval was obtained and verbal informed consent was collected from all participants.
详细描述
This study is a single-center, prospective, randomized, double-blind, placebo-controlled clinical trial conducted to evaluate the efficacy of prophylactic intravenous administration of ondansetron and dexamethasone in reducing the incidence and severity of postdural puncture headache (PDPH), and postoperative nausea and vomiting (PONV), in parturients undergoing elective cesarean section under spinal anesthesia.
A total of 150 parturients (ASA I or II), scheduled for cesarean delivery at Minia University Hospital, were randomly allocated into three parallel groups (1:1:1 ratio) using computer-generated randomization with sealed opaque envelopes to conceal allocation.
All patients received standard spinal anesthesia with 0.5% hyperbaric bupivacaine via a 25-gauge Quincke spinal needle in the sitting position at the L3-L4 or L4-L5 interspace. Prior to spinal anesthesia, patients in:
Group A (Ondansetron group) received 8 mg ondansetron IV (diluted to 5 mL in saline),
Group B (Dexamethasone group) received 8 mg dexamethasone IV (diluted to 5 mL),
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, Care Provider)
盲法说明
This was a double-blind study. Both the patients and the care providers (anesthesiologists) were blinded to the group assignments. Study medications were prepared in identical 5 mL syringes labeled A, B, or C by an independent supervisor who was not involved in patient care, drug administration, or data collection. Neither the participants nor the medical staff administering the anesthesia or assessing outcomes were aware of the group allocations
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ondansetron Group
Participants in this group received 8 mg of intravenous ondansetron diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia.
干预措施: Ondansetron 8mg (Drug)
Dexamethasone Group
Participants in this group received 8 mg of intravenous dexamethasone diluted to 5 mL with normal saline, administered 5 minutes before spinal anesthesia.
干预措施: Dexamethasone (Drug)
Placebo Group
Participants in this group received 5 mL of intravenous normal saline as placebo, administered 5 minutes before spinal anesthesia.
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of Postdural Puncture Headache (PDPH)
时间窗: Up to 14 days postoperatively
The primary outcome is the proportion of participants in each group who develop postdural puncture headache within 14 days following spinal anesthesia for elective cesarean section. Diagnosis is based on clinical criteria assessed during follow-up calls on postoperative days 7 and 14 by a blinded anesthesiologist.
次要结局
- Severity of PDPH(Up to 14 days postoperatively)
- Duration of PDPH(Up to 14 days postoperatively)
- Incidence of Nausea and Vomiting (N/V)(Intraoperatively and up to 4 days postoperatively)
- Neonatal Outcome (Apgar Score at 1 and 5 minutes)(At 1 minute and 5 minutes after birth)
研究者
Mokhtar Mostafa Mahran Mohamed
lecture
Minia University