A comparison of Ondansetron, Palonosetron and Granisetron for Prevention of Post-operative nausea and vomiting after Laparoscopic Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- To evaluate and compare the efficacy of ondansetron with palonosetron, and ondansetron with granisetron in prevention of Post-Operative Nausea and Vomiting (PONV).
研究概览
简要总结
Post-operative nausea and vomiting (PONV) has been an important concern in patients undergoing laparoscopic surgeries. Multiple agents have been used to treat PONV but 5-HT3 receptor antagonists are found be more effective with their potent anti-emetic effects. In our study, we aim to compare the effectiveness of ondansetron with different 5-HT3 receptor antagonists: palonosetron, and granisetron. A total of 135 patients will be randomly allocated into 3 groups with 45 patients in each group. Group O will receive Inj. Ondansetron 8mg intravenously, Group P will receive Inj. Palonosetron 0.075mg intravenously, and Group G will receive Inj. Granisetron 2.5mg intravenously prior to induction of anaesthesia. Patients will be monitored intraoperatively for vital parameters including heart rate, blood pressure, and oxygen saturation and postoperatively for possible side-effects of these agents including nausea, vomiting, headache, dizziness, allergy, constipation, etc. Thereafter, comparisons will be made among the two groups based on the data collected. The different variables and occurrence of side effects, if any, would also be noted and compared amongst all groups. Since this is a randomized prospective trial, the anticipated outcome cannot be commented upon.
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 and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.ASA grade I/II patients.
- •2.Patient receiving general anaesthesia for laparoscopic surgery.
排除标准
- •1.Refusal to participate in the study 2.Patients less than 18 or more than 65 years of age 3.Pregnant and lactating females 4.Morbid obesity (BMI>40 kg/m2) 5.Allergy to any of the anti-emetic drugs 6.History of PONV and motion sickness 7.Use of anti-emetic medication within 6 h prior to surgery 8.Use of high dose opioids prior to surgery 9.Patients with history of motion sickness, endocrine or metabolic disorders, hepatic or renal disease, gastrointestinal disorders and psychiatric diseases.
结局指标
主要结局
To evaluate and compare the efficacy of ondansetron with palonosetron, and ondansetron with granisetron in prevention of Post-Operative Nausea and Vomiting (PONV).
时间窗: prevention of nausea and vomiting for upto 24 hours after surgery
次要结局
- 1.To compare the side effect and haemodynamic profile on use of ondansetron, palonosetron and granisetron in patients undergoing laparoscopic surgeries under general anaesthesia.(2.To evaluate patient satisfaction scores.)