Efficacy of combination of Amisulpride-Ondansetron Vs. Dexamethasone-Ondansetron to prevent post operative nausea vomiting in middle ear surgeries-A randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare incidence and severity of PONV in middle ear surgeries between the two drugs.
研究概览
简要总结
Patients undergoing middle ear surgeries are at a higher risk of post operative episodes of nausea and vomiting. Amisulpride a selective D2/D3 dopamine antagonist has gained attention as an effective anti-emetic treatment for PONV prophylaxis. This study aims to evaluate the efficacy of Amisulpride versus the combination of dexamethasone and ondansetron for the prevention of PONV in patients undergoing middle ear surgeries. Amisulpride may offer advantages in terms of efficacy and tolerability. We plan to conduct the study since there is a paucity of clinical research comparing these two drugs in middle ear surgeries. Our primary objective is to compare incidence and severity of PONV in middle ear surgeries between the two drugs and secondary objective includes (1) Rescue anti-emetics used (2) Number of doses of rescue anti-emetics required (3) To analyze side effects of Amisulpride (4) Analgesia (Numerical rating scale) (5) Patient satisfaction (Discharge from PACU)
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 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex and belonging to ASA I and II category, undergoing middle ear surgeries under general anaesthesia.
排除标准
- •Patients who are pregnant,lactating,already on anti-emetics, history of psychiatric illness, central nervous system disorders, history of motion sickness, allergic to study drug.
结局指标
主要结局
To compare incidence and severity of PONV in middle ear surgeries between the two drugs.
时间窗: 0,15min,30min,1 hr, 2hr,4 hr, 6 hr, 12hr, 18hr, 24hr
次要结局
- 1.Rescue anti-emetics used(2. Number of doses of rescue anti-emetics required)
研究者
Dr Renita Anil
St. Johns Medical college Hospital, Bangalore