Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Presence of postoperative nausea and/or vomiting
研究概览
简要总结
The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.
详细描述
Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grade I and II
- •Aged 18-70 years
- •Patients scheduled for elective surgery under general anesthesia
排除标准
- •All patients who received antiemetics or cortisone within 48 hr before surgery
- •Pregnant, breast feeding ladies
- •Any patient with BMI (Body Mass Index) > 34 kg/m²
- •Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.
结局指标
主要结局
Presence of postoperative nausea and/or vomiting
时间窗: 24 hours
Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs
次要结局
未报告次要终点
研究者
AbdulRhman MA. M. Ibnouf
Dr.
Jordan Hospital