Effect of Ondansetron Lozenge Versus Intravenous for Prevention of Shivering in Cesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of shivering
研究概览
简要总结
This study aims to compare the effect of ondansetron lozenge and intravenous for prevention of shivering in cesarean section (CS).
详细描述
Spinal anesthesia has many advantages when used for cesarean section (CS). It is a popular technique with rapid onset and high success rate.
Shivering is associated with increased metabolic activity and consumption of oxygen. In addition, arterial hypoxia, lactic acidosis, and interference with electrocardiogram monitoring could be associated with shivering.
Ondansetron is a selective antagonist for receptor 5-hydroxytryptamine 3 and is very effective in the prevention and treatment of shivering intra- and post-operation. This medicine also decreases nausea and vomiting intra-and post-operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 40 years.
- •American Society of Anesthesiology (ASA) physical status II.
- •Parturient women undergoing cesarean section under spinal anesthesia.
排除标准
- •Parturient women with any contraindication or hypersensitivity to the study drugs.
- •Any history of cardiovascular diseases, psychosis, hypertension, fetal distress, cord prolapse initial.
- •Preoperative shivering.
- •Preoperative fever (>38°C).
- •Body mass index > 40 kg/m
- •Medical history of alcohol or drug abuse.
- •Hypo- or hyperthyroidism.
- •Parkinson's disease or any extrapyramidal disease.
- •Intraoperative blood transfusion.
研究组 & 干预措施
Group O
Patients will receive 8 mg of ondansetron IV just before the surgery.
干预措施: Ondansetron intravenous (Drug)
Group C
Patients will not receive ondansetron as a control group.
Group L
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
干预措施: Ondansetron lozenge (Drug)
结局指标
主要结局
Incidence of shivering
时间窗: 24 hours postoperatively
Shivering will be graded during the intraoperative and postoperative period using the scale validated by Crossley and Mahajan and Tsai and Chu. 0 No shivering 1. Piloerection or peripheral vasoconstriction but no visible shivering 2. Muscular activity in only one muscle group 3. Muscular activity in more than one muscle group but not generalized shivering 4. Shivering involving the whole body
次要结局
- Incidence of postoperative nausea and vomiting(24 hours postoperatively)
- Degree of patient satisfaction(24 hours postoperatively)
- Incidence of adverse effects(24 hours postoperatively)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta University