A double blind randomized control study to compare the antiemetic efficacy of ondansetron versus ondansetron and dexamethasone combination in patients undergoing breast surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Nausea and vomiting
研究概览
简要总结
Serotonin (5 Hydroxy tryptamine) receptor antagonists like ondansetron are the most commonly used drug for the prevention and treatment of Post-Operative nausea and vomiting (PONV) in all surgeries.
It has been found that there is a very high incidence of PONV in patients undergoing breast surgeries.
It has been found that the glucocorticoid, dexamethasone is a very potent and long acting anti emetic and it also augments the antiemetic property of other drugs.
Thus in our study we are comparing the efficacy of ondansetron alone or when used in combination with dexamethasone is better for preventing PONV and need for rescue antiemetic in patients undergoing breast surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- Female
入选标准
- •All females belonging to ASA I and II undergoing breaast surgeries.
排除标准
- •1.Patients on chronic steroid therapy , 2.pregnant/lactating women, 3.patients having history of motion sickness 4.patients on preoperative chemotherapy , 5.patients having received antiemetic ,steroid within 24hrs of surgery 6.patients suffering from diabetes mellitus, intestinal obstruction, hiatus hernia, hepatic and renal diseases 7.patients with prolonged QTC interval.
结局指标
主要结局
Nausea and vomiting
时间窗: within 24hrs after breast surgeries.
次要结局
- to assess the need for resscue antiemetic in 24hrs after breast surgery(within 24hours)
