Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting 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
- 75
- 试验地点
- 1
- 主要终点
- Incidence of postoperative nausea and vomiting (PONV)
研究概览
简要总结
The aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.
详细描述
Caesarean section has become increasingly popular, and it is the most performed surgical procedure. Despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. Around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (PONV).
PONV may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost.
The latest guidelines for the management of PONV recommend the administration of prophylactic antiemetic drugs (AED) as part of a multimodal therapy in high-risk adults.
Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 35 years old.
- •American Society of Anesthesiologists (ASA) physical status II.
- •Undergoing caesarean section under general anesthesia.
排除标准
- •Medical history of alcohol or drug abuse.
- •History of allergic reactions or intolerance to any study medications.
- •BMI > 40 kg/m
- •History of nausea and/or vomiting within 24 h prior procedures.
- •History of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure.
- •History of chemotherapy treatment within 4 weeks prior to surgery.
研究组 & 干预措施
Ondansetron lozenge (Ondalenz ©)
Patients will receive ondansetron lozenge 4 mg (Ondalenz ©), 2 hours before surgery.
干预措施: Ondansetron lozenge (Ondalenz ©) (Drug)
Ondansetron IV
Patients will receive 4 mg of ondansetron IV approximately 30 minutes before the end of surgery.
干预措施: Ondansetron IV (Drug)
结局指标
主要结局
Incidence of postoperative nausea and vomiting (PONV)
时间窗: 24 hours postoperatively
The incidence of nausea and vomiting will be evaluated through the Bellville scoring scale (lack of nausea and vomiting=0, nausea=1, nausea with belching=2, and vomiting=3).
次要结局
- Severity of postoperative nausea and vomiting (PONV)(24 hours postoperatively)
- Degree of patient satisfaction(24 hours postoperatively)
- Adverse effects(24 hours postoperatively)
研究者
ِAhmed Mohamed Ibrahim
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University