Comparison between Amisulpride and Ondansetron as an antiemetic for alleviating postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1. to evaluate the effectiveness of two antiemetics- ondansetron (1mg/kg) and amisulpride (5mg)- in controlling post operative nausea and vomiting after laparoscopic cholecystectomy
研究概览
简要总结
Laparoscopic cholecystectomy is now a procedure of choice for cholelithiasis and chronic cholecystitis. Laparoscopic procedures are being done under general anesthesia with muscle paralysis and controlled ventilation.Postoperative nausea and vomiting (PONV) is a common and a distressing complication after surgery. PONV maybe mild or transient, but its impact on patients can be much more severe, it can cause inability to mobilize after surgery, restricted oral intake, complications of protracted vomiting and delayed recovery and discharge after surgery. The main objective of the study is to compare between amisulpride and ondansetron as an antiemetic for alleviating PONV in patients undergoing Laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Physical status I or II Undergoing elective laparoscopic cholecystectomy willing to provide written informed consent.
排除标准
- •refusal to participate history of drug allergy to amisulpride or ondansetron pregnancy or gastroesophageal reflux disease history of cardiopulmonary diseases (asthma, COPD) Preoperative renal/hepatic dysfunction.
结局指标
主要结局
1. to evaluate the effectiveness of two antiemetics- ondansetron (1mg/kg) and amisulpride (5mg)- in controlling post operative nausea and vomiting after laparoscopic cholecystectomy
时间窗: 1. immediately after extubation | 2. within 6 hours of extubation | 3. within 12 hours of extubation | 4. within 24 hours of extubation
-to assess hemodynamic fluctuations and the side effects of ondansetron and amisulpride
时间窗: 1. immediately after extubation | 2. within 6 hours of extubation | 3. within 12 hours of extubation | 4. within 24 hours of extubation
-to assess the effectiveness of amisulpride and ondansetron preoperatively and postoperatively using quality of recovery 15 score
时间窗: 1. immediately after extubation | 2. within 6 hours of extubation | 3. within 12 hours of extubation | 4. within 24 hours of extubation
次要结局
未报告次要终点
研究者
Dr Sheetal Khattri
Himalayan institute of medical sciences