A comparative study of intravenous Granisetron and Ondansetron for the prophylaxis of postoperative nausea and vomiting following surgical procedures under general anaesthesia using inhalational agents: A prospective randomized
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the efficacy & safety of granisetron i.v. vs standard of care ondansetron i.v. in patients undergoing surgery under general anaesthesia.
研究概览
简要总结
PONV occurs in up to 40% of all patients who receive GA with inhalational drugs without any prophylaxis, but it can be as high as 80% in high-risk individuals. 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists have been demonstrated to be safe and effective in the prevention and treatment of PONV. Intravenous Ondansetron is the standard of care in this aspect. Though several studies have been undertaken to evaluate the preventive anti-emetic effects of these medicines in general anaesthesia, they have always been conducted on specific target groups with stringent inclusion and exclusion criteria.
In this study, we will administer intravenous Granisetron (2mg, single dose) or Ondansetron (4mg, single dose) to patients before the end of surgery for the prophylaxis of post-operative nausea and vomiting following surgical procedure under general anaesthesia using inhalational agents in order to investigate the prophylactic anti-emetic efficacy and safety of intravenous Ondansetron and Granisetron
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18yrs – 50 yrs -ASA grades I and II -Weighing more than 40 kg, -Those scheduled under general anaesthesia using inhalational agents will be included in the study.
排除标准
- •a) Patients not giving consent b) ASA grades III and IV patients.
- •c)Age < 18yrs and >50yrs.
- •d) Had taken antiemetic drugs within 24 hours before surgery.
- •e)Emergency surgeries & Full stomach f)History of motion sickness or previous PONV g)Total intravenous anesthesia.
结局指标
主要结局
To compare the efficacy & safety of granisetron i.v. vs standard of care ondansetron i.v. in patients undergoing surgery under general anaesthesia.
时间窗: First 24 hours, grouped as 0-1 hours,1-3 hours,3-6 hours,6-12 hours,12-24 hours post surgery
次要结局
- The effect of these drugs on clinical recovery, based on episodes of vomiting and recovery time. Nausea not considered as a symptom for the secondary outcome.(first 24 hours, post surgery)