Preoperative Ondansetron Lozenge for Prevention of Post-Spinal Shivering in Caesarean Section: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of shivering
研究概览
简要总结
The aim of this study is to estimate the role of ondansetron lozenge on prevention of post-spinal shivering in cesarean section.
详细描述
Spinal anesthesia (SA) is preferred for cesarean section (CS) compared with general anesthesia(GA) because of several advantages, including prevention of the potential risk of GA-related neurotoxicity.
Post-spinal shivering (PSS) could be a provocative factor for postoperative pain and its appropriate treatment prevents non-thermoregulatory tremors. Shivering also causes aggravating postoperative pain by stretching of sutures.
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. Ondansetron can affect the body temperature and shivering in rats since the balance of nor-epinephrine and 5-hydroxytryptamine (5-HT) in the preoptic-anterior hypothalamus controls the temperature set point.
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
- 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 CS 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.
- •Temperature more than 38°C or less than 36°C.
- •Body Mass Index (BMI)> 40 kg/m
- •Medical history of alcohol or drug abuse.
- •Parkinson's disease or any extrapyramidal disease.
- •Intraoperative blood transfusion.
- •History of chemotherapy treatment.
研究组 & 干预措施
Group S (Ondansetron lozenge)
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery as a study group.
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. Grades 3, and 4 shivering for at least 3 min will be considered positive, and maximum shivering will be considered if generalized shivering interfering with ECG monitoring or ability of the mother to hold the baby.
次要结局
- Incidence of postoperative nausea and vomiting (PONV)(24 hours postoperatively)
- Patients' satisfaction(24 hours postoperatively)
- 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