Comparison Of Palonosetron Versus Palonosetron With Dexamethasone In Prevention Of Postoperative Nausea And Vomiting After laparoscopic Cholecystectomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary objectives of this study is to assess the efficacy of monotherapy(palonosetron) vs combination therapy(palonosetron – dexamethasone) in preventing postoperative nausea and vomiting
研究概览
简要总结
â— Post-operative nausea and vomiting (PONV) is the second most common complaint in post-operative period after pain.
◠Although nausea and vomiting in post-operative period was reported to occur in 20%–30% of all laparoscopic surgeries and especially laparoscopic cholecystectomy significantly increases the incidence of PONV to as high as 50%.
â— Palonosetron is a second-generation 5-HT3 receptor antagonist having greater receptor binding affinity with a half-life of 40 h
â— Most of the literature and recent guidelines favours the use of dexamethasone and palonosetron, some studies differ in opinion.
In this context, we hypothesised that the combination of palonosetron and dexamethasone will be better antiemetic for PONV prophylaxis than the individual medication and this study was planned to accept or reject that hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologist Grade 1 & 2 Age between 18 and 60 years Patients posted for laparoscopic cholecystectomy.
排除标准
- •not willing to give consent age less than 18 yrs and more than 60yrs history of allergy to palonsetron and dexamethasone electrolyte abnormalities patient with drug history of SSRI and drugs which cause QT prolongation.
结局指标
主要结局
Primary objectives of this study is to assess the efficacy of monotherapy(palonosetron) vs combination therapy(palonosetron – dexamethasone) in preventing postoperative nausea and vomiting
时间窗: 2 years
次要结局
- Secondary objective is to study the number of rescue doses of antiemetics needed.(2 years)
研究者
Dr Kondamuru Likhitha
Dr. Pinnamaneni Siddhartha Institute of Medical Sciences and Research Foundation