To Compare Safety And Efficacy Of Low Dose And High Dose Of Intravenous Amisulpride In Prevention Of Nausea And Vomiting In Middle Ear Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To note occurrence of Intraoperative Nausea and Vomiting
研究概览
简要总结
This study aims to compare the safety and efficacy of low-dose (5mg) and high-dose (10mg) intravenous amisulpride in preventing postoperative nausea and vomiting (PONV) in patients undergoing middle ear surgeries. These surgeries increase the risk of PONV due to vestibular stimulation from drilling and irrigation. Amisulpride, a D2-D3 antagonist, has shown effectiveness in preventing PONV, though the optimal dose remains unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient posted for Elective Middle Ear Surgeries Patient giving written and informed consent American Society of Anesthesiologist (ASA) grade I-II[7] Age group of 18-65 years old Apfel Score ≥ 2.
排除标准
- •Patient on any Psychotropic drug smokers Pregnant Females.
结局指标
主要结局
To note occurrence of Intraoperative Nausea and Vomiting
时间窗: Baseline( At time of Extubation) | 15 mins | 30 mins | 45 mins | 1 hour | 2 hours | 3 hours | 4 hours | 8 hours | 12 hours | 24 hours
To compare severity of Nausea Vomiting for 24 hours
时间窗: Baseline( At time of Extubation) | 15 mins | 30 mins | 45 mins | 1 hour | 2 hours | 3 hours | 4 hours | 8 hours | 12 hours | 24 hours
次要结局
- To compare the time for onset of first episode of Nausea Vomiting(To compare the efficacy of intravenous amisulpride by noting the Verbal Rating Score (VRS))
研究者
Dr Paigam Prinja
Teerthanker Mahaveer Medical College and Research Centre