Comparison of amisulpride and ondansetron for prevention of post operative nausea and vomiting following laparoscopic cholecystectomy
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To compare the incidence of postoperative nausea and vomiting following premedication with amisulpride and ondansetron in patients undergoing laparoscopic cholecystectomy
研究概览
简要总结
Laparoscopic cholecystectomy is one of the most common surgical procedures performed for the removal of the gallbladder. The most common post operative problem reported after laparoscopic cholecystectomy is nausea and vomiting with prevalence of 27.7 percent.
Postoperative nausea and vomiting (PONV) causes dehydration, electrolyte imbalance and leads to discomfort and extended hospital stay. It also increases the risk of complications like aspiration pneumonia and wound dehiscence. Overall, it reduces the quality of life of patients and adds considerably to resource use and costs.
Several agents like 5HT3 antagonists, metoclopramide and domperidone are widely used as prophylaxis for postoperative nausea and vomiting but they are associated with sedation and extrapyramidal symptoms. Amisulpride is a selective dopamine (D2 and D3) antagonist that has been shown to be effective as a prophylactic antiemetic as well as a rescue treatment for postoperative nausea and vomiting. It has a better safety profile and more targeted action on D2 receptors in Chemoreceptor trigger zone of brain. It also has an additional benefit of minimal QT prolongation, which was a major concern with other D2 antagonists like droperidol.
Ondansetron is a 5HT3 receptor antagonist, which is considered to be very effective for postoperative nausea and vomiting management. Studies have shown promising results with amisulpride for postoperative nausea and vomiting in various clinical settings, but its application specifically in laparoscopic cholecystectomy remains unexplored. Studies comparing amisulpride with other antiemetics like ondansetron are lacking, hence this study comparing the efficacy of amisulpride to ondansetron is needed. The present study was designed to test the hypothesis that a single, preoperative 5mg IV dose of amisulpride was more effective than a single, preoperative 8mg IV dose of ondansetron at preventing PONV in adults undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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 anaesthesiologists ASA physical status 1 and 2 weight 40kg to 70kg.
排除标准
- •Patient refusal Patients with known allergy to study drug Patients coming for any emergency surgeries Patient with history of motion sickness or dizziness or vestibular disease Known prolactin dependent tumour or phaeochromocytoma Documented clinically significant cardiac arrythmia or long QT syndrome Pregnant or breastfeeding History of epilepsy, parkinsons, treatment with levodopa Received any emetogenic anticancer therapy in previous 4 weeks Pre existing nausea or vomiting in the 24 hours before surgery Patients being treated with regular antiemetic therapy including systemic corticosteroids.
结局指标
主要结局
To compare the incidence of postoperative nausea and vomiting following premedication with amisulpride and ondansetron in patients undergoing laparoscopic cholecystectomy
时间窗: Nausea and vomiting assessed postoperatively at the following time points | 2hours after surgery | 6 hours after surgery | 12 hours after surgery | 24 hours after surgery
次要结局
未报告次要终点
研究者
Srushti Shankar Hireraddi
MS Ramaiah Medical College