Comparison Between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks During Caesarean Delivery With Spinal Anesthesia: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Incidence of nausea and vomiting with spinal anesthesia
研究概览
简要总结
Single shot spinal anesthesia is widely used for most surgical operations especially in obstetric such as hysterectomy, tubal ligation after vaginal delivery, cesarean and curettage etc.; however, in general, cesarean is considered as the most common indication for spinal anesthesia in pregnant women Intra-operative nausea and vomiting/retching (NVR) may be experienced by 20% to 80% of women undergoing cesarean section (CS) with subarachnoid anesthesia (SA) in the absence of antiemetic prophylaxis.
Different treatment options are available to reduce post operative nausea and vomiting (PONV) so we will make a Comparison between Propofol, Ondansetron and Pregabalin for Control of Emetic Attacks during Caesarean Delivery with Spinal Anesthesia
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
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 21-40 years old.
- •Physical status American Society of Anesthesiologists (ASA)I&II.
- •Body mass index (BMI) < 35&>20 kg/m
- •Elective uncomplicated cesarean section under spinal anesthesia.
排除标准
- •Patient refusal.
- •Patients with known history of allergy to study drugs.
- •Advanced hepatic, renal and respiratory diseases.
- •Psychological and mental disorders.
- •Patient with reduced level of consciousness.
- •Hypertensive, cardiac, and diabetic patients.
- •Patients receiving anticoagulants therapy or suspected coagulopathy.
研究组 & 干预措施
propofol
30 Patients will receive propofol as equal volumes of both 1% of propofol 10mg/ml and0.9% normal saline will be drawn in a 20-ml syringe before spinal puncture.
干预措施: Propofol (Drug)
pregabalin
30 Patients will receive three capsules of pregabalin 100 mg once one hour before the surgical incision.
干预措施: Propofol (Drug)
ondansetron
30 Patients will receive 4 mg ondansetron in 10 ml saline intravenously 5 min before spinal puncture.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence of nausea and vomiting with spinal anesthesia
时间窗: 5 months
To compare between Propofol, Ondansetron and Pregabalin for control of emetic attacks during caesarean delivery with spinal anesthesia.
次要结局
- Measurement of hemodynamics postoperative(5 months)
研究者
Ebtehal Ahmed Abdellattif
resident at Anesthesiology, Surgical Intensive Care and Pain Medicine department
Sohag University