To Study the Efficacy and Safety of Intravenous Amisulpride against Ondansetron in Post-Surgical Patients undergoing general Anaesthesia to Prevent Post Operative Nausea Vomiting (PONV)- An Interventional, Randomised, Controlled Prospective Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete response of medicine that is no episodes of emesis and no use of rescue medication in first 24 hours after wound closure or PONV.
研究概览
简要总结
Traditionally ondansetron is used as an antiemetic to prevent post-operative nausea and vomiting (PONV), which is a 5HT3 Receptor blocker. Amisulpride is a dopamine receptor antagonist with less incidence of extrapyramidal symptoms in a safe dose range from 50- 1200 mg. Now it is recently available as (Sultran 5mg/ 2ml preparation in India) an antiemetic drug to prevent post-operative nausea and vomiting. So we have to study the efficacy and safety of intravenous amisulpride against ondansetron in post-surgical patients undergoing general anaesthesia to prevent post-operative nausea and vomiting (PONV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •â€¢ Surgery to last at least 1 hour • Overnight stay • General anaesthesia • ASA I&II • At least one of the following Apfel et al’s risk factors for PONV:  Female sex  Non-smoking status  A prior history of PONV or motion sickness  Being expected to receive postoperative opioid analgesia.
排除标准
- •If any antihistaminic, continuous infusion of propofol or dexmedetomidine, steroids, any antiemetics is used 24 hours prior or post-surgery then the case will be not selected for the study.
结局指标
主要结局
Complete response of medicine that is no episodes of emesis and no use of rescue medication in first 24 hours after wound closure or PONV.
时间窗: 0,2,6,8,12,24,48 hours
次要结局
- To observe the incidence of nausea, emesis, use of rescue medication any adverse event.(0,2,6,8,12,24,48 hours)
研究者
Dr Tejash H Sharma
Dept. of Anaesthesiology, SBKS MIRC