Comparison of Palonosetron and Ondansetron for the Prevention of Postoperative Nausea and Vomiting After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Nause and vomiting 6hr
研究概览
简要总结
Evaluate the safety and efficacy of palonosetron versus ondansetron to reduce and control post-operative nausea in bariatric surgery.
详细描述
Postoperative nausea and vomiting (PONV) is an undesirable clinical condition that increases the likelihood of dehiscence, bleeding, pulmonary aspiration of gastric contents, and electrolyte loss that lead to increased costs, prolonged hospital stays, and delayed recovery. In recent years, selective serotonin 5-hydroxytryptamine sub-type 3 (5-HT3) receptor antagonists such as ondansetron, granisetron, palonosetron have been introduced because they are effective in the prevention and treatment of PONV in bariatric surgery. In this study, the effects of ondansetron and palonosetron on PONV in patients who undergo sleeve gastrectomy will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All morbidity obese patients underwent laparoscopic sleeve gastrectomy
排除标准
- •drug allergy, intractable nausea and vomiting, gastroesophageal reflux disease, pregnancy, menstruation, the occurrence of nausea or vomiting episodes in the last 24 h prior to surgery, the use of corticosteroids, smoking, alcoholism, the use of psychoactive drugs or any other drug with antiemetic effects, hypersensitivity to other 5-HT3 antagonists, emergency surgeries and chemotherapy within.
研究组 & 干预措施
Ondansetron
In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
Ondansetron
In Group B (n = 50): Intravenous injection of ondansetron 0.1 mg/kg diluted up to 5 mL with normal saline solution in a maximum dose of 8 mg is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
干预措施: Ondansetron 1 mg/kg, max dose 8 mg (Drug)
Palonosetron
The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
Palonosetron
The antiemetics used are palonosetron in Group A (n = 50): Intravenous injection of Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution is performed at the end of bariatric surgery while patients are in anesthesia. The drug is injected once.
干预措施: Palonosetron 1mcg/kg (Drug)
结局指标
主要结局
Nause and vomiting 6hr
时间窗: postoperative 6 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 24hr
时间窗: postoperative 24 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 48hr
时间窗: postoperative 48 hours
Visual Analog Scale score for nausea and vomiting
Nause and vomiting 72hr
时间窗: postoperative 72 hours
Visual Analog Scale score for nausea and vomiting
amount of rescue anti-emetic drugs
时间窗: postoperative seventh day
Number of anti emetic metoclopramide intravenous injections during hospitalization and the postoperative one week.
次要结局
- Pain 72hr(postoperative 72 hours)
- Pain 48hr(postoperative 48 hours)
- Pain 6hr(postoperative 6 hours)
- Pain 24hr(postoperative 24 hours)
研究者
Nadir Adnan Hacım
Pirincipal investigator Adnan
Bagcilar Training and Research Hospital